Walid M. Awni

Abbott Laboratories, North Chicago, Illinois, United States

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Publications (131)666.43 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Direct-acting antiviral agents (DAAs) are established as the standard of care for chronic hepatitis C virus (HCV) infection. One of the newest additions to the HCV arsenal is an oral three-DAA combination therapy (i.e., the 3D regimen) that does not require concomitant use of pegylated interferon. The clinical development program for the 3D regimen has yielded a robust dataset that is inclusive of various dosing schemes and a diverse patient population. Using data from nine phase 1b/2a/2b studies that enrolled patients with HCV genotype 1 infection, population pharmacokinetic models were developed for each component of the 3D regimen (ombitasvir, paritaprevir, ritonavir, and dasabuvir) and for ribavirin, an adjunctive therapy used to enhance therapeutic efficacy in some populations. Formulation effects, accumulation, relative bioavailability, and interactions between DAAs were assessed during model development, and demographic and clinical covariates were identified and evaluated for their effects on drug exposures. Proposed models were assessed via goodness-of-fit plots, visual predictive checks, and bootstrap evaluations. Population pharmacokinetic models adequately described their respective plasma concentration-time data with precise and reliable model parameter estimates and with good predictive performance. Covariates, including age, sex, body weight, cytochrome P450 2C8 inhibitor use, non-Hispanic ethnicity, and creatinine clearance, were associated with apparent clearance and/or apparent volume parameters; however, the magnitude of effect on drug exposure was modest and not considered to be clinically significant. No patient-related or clinical parameters were identified that would necessitate dose adjustment of the 3D regimen in patients with HCV genotype 1 infection.
    The AAPS Journal 11/2015; DOI:10.1208/s12248-015-9846-1 · 3.80 Impact Factor
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    ABSTRACT: The 3D regimen of ombitasvir (NS5A inhibitor), paritaprevir (NS3/4A inhibitor) coadministered with ritonavir (r), and dasabuvir (NS5B non-nucleoside polymerase inhibitor) and the 2D regimen of ombitasvir/paritaprevir/r have demonstrated high efficacy with and without ribavirin in HCV-infected subjects. These regimens have potential for coadministration with sofosbuvir (nucleoside NS5B inhibitor) in the treatment of HCV. This Phase 1, drug-drug interaction, open-label, multiple-dose study enrolled 32 healthy subjects to receive the 3D or 2D regimen in combination with sofosbuvir. Doses of study drugs were: ombitasvir/paritaprevir/r 25/150/100 mg QD, dasabuvir 250 mg BID, and sofosbuvir 400 mg QD. Blood samples were collected on Study Days 7, 14 and 21 for evaluating drug interaction at steady-state. The effect of the 3D and 2D regimens on the pharmacokinetics of sofosbuvir and its circulating metabolite GS-331007 and vice versa was assessed by a repeated-measures analysis. Exposures of the 3D and 2D regimens were similar (≤ 20% change) during coadministration with sofosbuvir compared to alone. Sofosbuvir exposures were 61% to 112% higher with the 3D regimen and 64% to 93% higher with the 2D regimen compared to sofosbuvir alone. GS-331007 total exposures were 27% and 32% higher with the 3D and 2D regimen, respectively, compared to sofosbuvir alone. Increases in sofosbuvir and GS-331007 exposures likely resulted from BCRP and/or P-gp transporter inhibition by paritaprevir and ritonavir. No subjects discontinued the study due to study drug-related adverse events. No dose adjustment is recommended for 3D, 2D or sofosbuvir in clinical trials exploring the safety and efficacy of the combination.
    Antimicrobial Agents and Chemotherapy 11/2015; DOI:10.1128/AAC.01913-15 · 4.48 Impact Factor
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    ABSTRACT: The 2D regimen of ombitasvir and paritaprevir (administered with low-dose ritonavir) is being developed for treatment of genotype subtype 1b and genotypes 2 and 4 chronic hepatitis C virus (HCV) infection. Drug-drug interactions were evaluated in healthy volunteers to develop dosing recommendations for HCV-infected subjects. Mechanism-based interactions were evaluated for ketoconazole, pravastatin, rosuvastatin, digoxin, warfarin, and omeprazole. Interactions were also evaluated for duloxetine, escitalopram, methadone, and buprenorphine/naloxone. Ratios of geometric means with 90% confidence intervals for maximum plasma concentration and area under the plasma concentration-time curve were estimated to assess the magnitude of interaction. For most medications, coadministration with the 2D regimen resulted in a < 50% change in exposures. Ketoconazole, digoxin, pravastatin, and rosuvastatin exposures increased by up to 105%, 58%, 76%, and 161%, respectively, and omeprazole exposures decreased by approximately 50%. Clinically meaningful changes in ombitasvir, paritaprevir, or ritonavir exposures were not observed. In summary, all 11 evaluated medications can be coadministered with the 2D regimen, with most medications requiring no dose adjustment. Ketoconazole, digoxin, pravastatin, and rosuvastatin require lower doses and omeprazole may require a higher dose. No dose adjustment is required for the 2D regimen.
    Antimicrobial Agents and Chemotherapy 10/2015; DOI:10.1128/AAC.01778-15 · 4.48 Impact Factor
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    ABSTRACT: Paritaprevir, ombitasvir, and dasabuvir are direct-acting antivirals for treatment of chronic hepatitis C virus (HCV) infection. The aim of this study was to characterize the effects of mild, moderate, and severe hepatic impairment on the pharmacokinetics of these drugs. HCV-negative subjects with normal hepatic function (n = 7) or mild (Child-Pugh A, n=6), moderate (Child-Pugh B, n = 6), or severe (Child-Pugh C, n = 5) hepatic impairment received a single dose of the combination of paritaprevir plus ritonavir (paritaprevir/r, 200/100 mg), ombitasvir (25 mg), and dasabuvir (400 mg). Plasma samples were collected through 144 hours after administration for pharmacokinetic assessments. Paritaprevir, ombitasvir, dasabuvir, and ritonavir exposures (maximal plasma concentration, Cmax, and area under the concentration-time curve, AUC) were minimally affected in subjects with mild or moderate hepatic impairment. Differences in exposures between healthy controls and subjects with mild or moderate hepatic impairment were less than 35%, except for 62% higher paritaprevir AUC in subjects with moderate hepatic impairment. Paritaprevir and dasabuvir AUC were significantly higher in subjects with severe hepatic impairment (950% and 325%, respectively). However, ombitasvir AUC was 54% lower and ritonavir AUC was comparable. Adverse events included eye stye, insomnia, and pain from an infiltrated intravenous line. The changes observed in paritaprevir, ritonavir, ombitasvir, and dasabuvir exposures in subjects with mild or moderate hepatic impairment do not necessitate dose adjustment. Subjects with severe hepatic impairment had substantially higher paritaprevir and dasabuvir exposures. Copyright © 2015. Published by Elsevier B.V.
    Journal of Hepatology 06/2015; 63(4). DOI:10.1016/j.jhep.2015.05.029 · 11.34 Impact Factor

  • Journal of Hepatology 04/2015; 62:S644. DOI:10.1016/S0168-8278(15)31023-0 · 11.34 Impact Factor

  • Gastroenterology 04/2015; 148(4):S-275-S-276. DOI:10.1016/S0016-5085(15)30905-7 · 16.72 Impact Factor
  • A. Khatri · S. Mensing · T. Podsadecki · W. Awni · R. Menon · S. Dutta ·

    Journal of Hepatology 04/2015; 62:S682. DOI:10.1016/S0168-8278(15)31105-3 · 11.34 Impact Factor
  • J. King · S. Dutta · D. Cohen · T. Podsadecki · B. Ding · W. Awni · R. Menon ·

    Journal of Hepatology 04/2015; 62:S683-S684. DOI:10.1016/S0168-8278(15)31108-9 · 11.34 Impact Factor
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    ABSTRACT: Adalimumab, a fully human monoclonal antibody (IgG1κ) to tumor necrosis factor, has shown benefit in the treatment of inflammatory bowel disease. The purpose of this analysis was to evaluate the pharmacokinetics (PK) and the serum concentration-efficacy relationship of adalimumab in pediatric patients with moderate-to-severe Crohn's disease. The safety, efficacy, and PK of adalimumab was evaluated in a phase-3, randomized, double-blind, 52-week study (IMAgINE-1, N = 192), which had a 4-week open-label induction phase (dose was determined by patient weight) followed by a 48-week double-blind maintenance phase (standard and low-dose arms, drug given every other week). Trough serum adalimumab (baseline, weeks 2, 4, 16, 26, and 52) and anti-adalimumab antibody measurements (baseline, weeks 16, 26, and 52) were collected. Disease activity was assessed using the Pediatric Crohn's Disease Activity Index. At week 52, adalimumab trough concentrations (mean ± SD) were higher for patients in the standard-dose (9.48 ± 5.61 μg/mL) compared with the low-dose (3.51 ± 2.21 μg/mL) arm. In patients whose doses were increased from every other week to weekly, higher trough concentrations were observed after dose escalation. Higher body weight, baseline C-reactive protein, and lower baseline albumin levels were associated with greater clearance of adalimumab. An exposure (serum concentration)-efficacy relationship was observed, in which higher concentrations of adalimumab were associated with greater rates of remission. This study is the first to describe the PK of adalimumab in pediatric patients with moderate-to-severe Crohn's disease. A positive association between serum adalimumab concentration and remission/response was identified.
    Inflammatory Bowel Diseases 02/2015; 21(4). DOI:10.1097/MIB.0000000000000327 · 4.46 Impact Factor
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    ABSTRACT: ABT-450, ombitasvir, and dasabuvir are direct-acting antiviral agents (DAAs) that have been developed for combination treatment of chronic hepatitis C virus (HCV) infection. Because these DAAs have metabolic and transporter profiles that overlap with cyclosporine and tacrolimus disposition, there is potential for drug interactions. Two Phase 1 studies assessed effects of ABT–450 (150mg coadministered with ritonavir 100mg once daily), ombitasvir (25mg once daily), and dasabuvir (400mg twice daily) on the pharmacokinetics, safety, and tolerability of a single dose of cyclosporine (30 mg) or tacrolimus (2 mg) in healthy volunteers (N=12 per study). In the presence of steady-state concentrations of all 3 DAAs, dose-normalized cyclosporine concentration at 24 hours (C24), and area under the concentration-time curve from time 0 to infinity (AUC1) were 15.8-fold and 5.8-fold, respectively, and dose-normalized tacrolimus C24 and AUC1 were 17-fold and 57-fold, respectively, of either agent alone. Cyclosporine and tacrolimus half-lives increased from 7 to 25 h and 32 to 232 h, respectively. There were no major safety or tolerability issues in these studies. The results suggest that cyclosporine and tacrolimus doses and dosing frequency should be reduced in HCV-infected posttransplant patients being treated with this 3-DAA regimen.
    American Journal of Transplantation 02/2015; 15(5). DOI:10.1111/ajt.13111 · 5.68 Impact Factor

  • Annual Meeting of the; 02/2015
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    ABSTRACT: Background & aims: Paritaprevir (administered with ritonavir, PTV/r), ombitasvir (OBV), and dasabuvir (DSV) are direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection. Thirteen studies were conducted to characterize drug-drug interactions for the 3D regimen of OBV, PTV/r, and DSV and various medications in healthy volunteers to inform dosing recommendations in HCV-infected patients. Methods: Mechanism-based drug-drug interactions were evaluated for gemfibrozil, ketoconazole, carbamazepine, warfarin, omeprazole, digoxin, pravastatin, and rosuvastatin. Drug-drug interactions with medications commonly used in HCV-infected patients were evaluated for amlodipine, furosemide, alprazolam, zolpidem, duloxetine, escitalopram, methadone, buprenorphine/naloxone, and oral contraceptives. Ratios of geometric means with 90% confidence intervals for maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) were used to determine the magnitude of interaction. Results: Coadministration with the 3D regimen of OBV, PTV/r, and DSV resulted in a <2-fold change in mean Cmax and AUC for most medications and the DAAs, indicating minimal to modest interactions. Carbamazepine decreased PTV, ritonavir, and DSV exposures substantially, while gemfibrozil increased DSV exposures substantially. Although coadministration with ethinyl estradiol-containing contraceptives resulted in elevated alanine aminotransferase levels, coadministration with a progestin-only contraceptive did not. Conclusions: The majority of medications can be coadministered with the 3D regimen of OBV, PTV/r, and DSV without dose adjustment, or with clinical monitoring or dose adjustment. Although no dose adjustment is necessary for the 3D regimen when coadministered with 17 of the 20 medications, coadministration with gemfibrozil, carbamazepine, or ethinyl estradiol-containing contraceptives is contraindicated.
    Journal of Hepatology 01/2015; DOI:10.1016/j.jhep.2015.01.026 · 11.34 Impact Factor
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    ABSTRACT: ABT-639 is a selective T-type calcium channel blocker with efficacy in a wide range of preclinical models of nociceptive and neuropathic pain. In the current first-in-human (FIH) study, the pharmacokinetics, tolerability, and safety of ABT-639 after single- (up to 170 mg) and multiple doses (up to 160 mg BID) were evaluated in healthy volunteers in a randomized, double-blinded, placebo-controlled manner. ABT-639 demonstrated acceptable safety and pharmacokinetic profiles in human. Results from assessment of the routine laboratory variables showed an unexpected statistically significant and clinically relevant decrease in blood uric acid with the increase in ABT-639 dose, which is possibly due to inhibition in URAT1 transporter. Pharmacokinetic/pharmacodynamic models were constructed to characterize the relationship between ABT-639 exposure and uric acid response. The final model was a mechanism-based indirect response pharmacodynamic model with the stimulation of uric acid elimination by ABT-639. The model estimated K in values in males and females were 10.2 and 7.13 μmol/h, respectively. The model estimated K out was 0.033 1/h. ABT-639 concentration that can produce 50% stimulation in uric acid elimination was estimated to be 8,070 ng/mL. Based on the final model, further simulations were conducted to predict the effect of ABT-639 on uric acid in gout patients. The simulation results indicated that, if the urate-lowering response to ABT-639 in gout patients is similar to that in healthy subjects, ABT-639 BID doses of 140 mg or higher would be expected to provide clinically meaningful lowering of blood uric acid levels below the 380 μmol/L solubility limit of monosodium urate.
    The AAPS Journal 01/2015; 17(2). DOI:10.1208/s12248-014-9709-1 · 3.80 Impact Factor
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    ABSTRACT: ABT-384 is a potent and selective inhibitor of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1). ABT-384 pharmacokinetics was evaluated in healthy volunteers in single-dose (1, 8, 20, 50, 120 and 240 mg) and multiple-dose studies (1, 2, 4, 8, 20, 30 and 100 mg). Less than dose-proportional pharmacokinetics of ABT-384 was observed when ABT-384 was administered at single doses lower than 8 mg. This nonlinear phenomenon disappeared after repeated doses. The dose-normalized plasma concentration-time curves superposed across all dose groups on Day 7, but not on Day 1. This phenomenon cannot be explained by the half-life of ABT-384. Based on available data, the nonlinearity is likely due to binding of ABT-384 to a high-affinity-low-capacity site, such that this interaction was reflected in ABT-384 pharmacokinetics. To characterize pharmacokinetics of ABT-384, a population pharmacokinetic model for ABT-384 was constructed. The model provided reasonable fitting for both single- and multiple-dose data. Further investigation is warranted to evaluate the disposition of ABT-384 at low doses using a larger number of subjects. The constructed model would be useful in predicting ABT-384 concentrations at different doses and guiding selection of dosing regimens in further clinical trials. This article is protected by copyright. All rights reserved.
    Biopharmaceutics & Drug Disposition 10/2014; 35(7). DOI:10.1002/bdd.1912 · 2.34 Impact Factor
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    ABSTRACT: Lortab® Elixir, a proprietary combination product containing hydrocodone and acetaminophen, is approved in the U.S. for the treatment of moderate to moderately severe pain in children. Despite this approval, pediatric pharmacokinetic data using this product have not been previously published. Using a single-dose open-label study approach, we evaluated the pharmacokinetics, tolerability and safety of this product in 17 healthy children 6 to 17 years of age. Results showed that the body weight-normalized oral clearance (L/hr/kg) of hydrocodone and acetaminophen were 42% and 27% higher, respectively when compared to data from healthy adults. This suggests thathigher mg/kg dose, but not the absolute dose, would be required in children to achieve exposures similar to adults. We found adjustment of hydrocodone and acetaminophen dose by body surface area to be more optimal than body weight based dose adjustment for achieving similar systemic exposure in children and adults. However, body weight-based hydrocodone and acetaminophen dosing regimen provided close approximation of adult exposuresin pediatric patients with approximately 22% to 24% lower hydrocodone and acetaminophen dose/BW-normalized AUC in pediatric patients compared to adults. Finally, the adverse event profile in our pediatric cohort was consistent with that expected of opioid-naive subjects receiving opioid-combination therapy.
    The Journal of Clinical Pharmacology 09/2014; 55(2). DOI:10.1002/jcph.394 · 2.48 Impact Factor
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    ABSTRACT: Objective: Navitoclax is a first-in-class, orally bioavailable, targeted Bcl-2 family protein inhibitor and promotes apoptosis. Thrombocytopenia is a primary dose-limiting toxicity of navitoclax which exhibited a distinct time profile in circulating platelets from that caused by traditional chemotherapies. A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed to describe the pharmacokinetic of navitoclax as well as the time course of the platelet counts in cancer patients receiving navitoclax. Methods: Data from 256 patients who received oral navitoclax (dose range 10-475 mg) as a 14/21-day schedule or a continuous once daily (QD) schedule were used to construct the model using NONMEM. The PK model was a two-compartmental model with a lag-time and a transit compartment in absorption. The PD model was a semi-physiological model that comprised a progenitor cell compartment, three transition compartments representing the maturation chain in the bone marrow and a peripheral blood compartment. Compared with the previously published models, the model established in this analysis applied a different feedback mechanism and introduced a new concept of progenitor cell "pool", which describes a large pool of platelet progenitor cells at the beginning of navitoclax treatment. Results: The PD model was able to describe a slight downward trend of platelet counts over the long-term navitoclax treatment as observed in around 8 % of the patients and the initial drop in platelets seen in our Phase 1/2a studies. Conclusions: We have developed a new semi-physiological platelet model for describing fast drop of platelets after initial navitoclax administration and long-term decline of platelets after continuous administration of navitoclax.
    Cancer Chemotherapy and Pharmacology 07/2014; 74(3). DOI:10.1007/s00280-014-2530-9 · 2.77 Impact Factor
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    ABSTRACT: Background: Biopharmaceutical studies for anti-cancer drugs are typically conducted in cancer patients due to unacceptable toxicities to healthy volunteers. Navitoclax is a first-in-class, orally bioavailable, targeted Bcl-2 family protein inhibitor that has been studied in cancer patients. Methods: A strategy that integrated the evaluation of non-clinical toxicology data and clinical data in cancer patients was employed to assess the feasibility, determine doses and establish risk management plans for studying navitoclax in healthy volunteers. Two relative bioavailability/food effect studies with either a 25 mg dose or 50 and 100 mg doses of navitoclax were conducted sequentially in healthy female volunteers of non-childbearing potential. Results/conclusion: Navitoclax was well-tolerated in both studies in healthy volunteers, and did not impose risks beyond the minimal levels expected in healthy volunteer studies. Compared to a similar study in cancer patients, the studies in healthy volunteers generated higher quality data in a short period of time to support formulation selection.
    Anticancer research 07/2014; 34(7):3739-46. · 1.83 Impact Factor
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    ABSTRACT: Linifanib is a selective inhibitor of the vascular endothelial growth factor and platelet-derived growth factor family of tyrosine kinase inhibitors. The purpose of this high-precision QT study was to evaluate the effects of linifanib on cardiac repolarization in patients with advanced metastatic tumors. Enrolled patients (n = 24) had measurable disease refractory to standard therapies, ECOG performance status of 0-1, and adequate organ function. Patients were randomized in a 2-sequence, 2-period crossover design. Serial ECG measurements and pharmacokinetic samples were collected for each crossover period. An intersection-union test was performed for time-matched baseline-adjusted QTcF intervals. An exposure-response analysis was explored to correlate the plasma concentration and QTcF. The maximum 95 % upper confidence bound for the baseline-adjusted QTcF was 4.3 ms at hour 3 at the maximum tolerated linifanib dose of 0.25 mg/kg. Linifanib did not meet the regulatory threshold (10 ms) for QT prolongation. Exposure-response modeling showed that the QTcF change was not significant at the maximum plasma concentration. Linifanib does not significantly affect cardiac repolarization in patients with advanced solid tumors.
    Cancer Chemotherapy and Pharmacology 11/2013; 73(1). DOI:10.1007/s00280-013-2351-2 · 2.77 Impact Factor
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    ABSTRACT: ABT-384 is a potent and selective inhibitor of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1), the enzyme that regenerates cortisol in several tissues. Two clinical studies of ABT-384 were undertaken to assess its safety, pharmacokinetics, target engagement, and pharmacologic effects in healthy subjects. Single doses from 1 to 240 mg, and multiple doses from 1 to 100 mg once daily for 7–14 days, were administered to healthy adults. Multiple doses from 10 to 100 mg once daily for 21 days were administered to elderly subjects. A total of 103 subjects received at least 1 dose of ABT-384. A maximum-tolerated dose was not defined in either study. The pharmacokinetic profiles of ABT-384 and its active metabolite support once daily dosing. Analysis of urine cortisol metabolites demonstrated full hepatic HSD-1 inhibition with regimens from 1 mg daily, and confirmed in vitro target selectivity. Pharmacologic effects included increases of adrenocorticotrophic hormone levels, cortisol production and androgen and estradiol levels. ABT-384 has a wide therapeutic index relative to full hepatic target engagement which is relevant for indications such as diabetes and metabolic syndrome. Its therapeutic index for other potential indications such as Alzheimer's disease remains to be established.
    Clinical Pharmacology in Drug Development 04/2013; 2(2). DOI:10.1002/cpdd.5
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    ABSTRACT: ABT-384 is a potent and selective inhibitor of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1). ABT-384 has been shown to be safe and well tolerated in man at doses up to 100 mg QD, and to fully inhibit both peripheral and brain HSD-1 at a dose of 2 mg QD. The effect of ketoconazole on the pharmacokinetics of ABT-384 and its two active metabolites A-1331480 and A-847082 was investigated in healthy volunteers. When 10 mg of ABT-384 was co-administered with ketoconazole, ABT-384 exposures increased 18-fold for AUC∞ and 3.5-fold for C(max). The results suggest that ABT-384 is a sensitive substrate of CYP3A. After ketoconazole co-administration, exposures of A-1331480 and A-847082 were also greatly increased. A population pharmacokinetic modeling was constructed for ABT-384 and its metabolites using NonMEM. A 2-compartment model with 3 transit absorption compartments best described ABT-384 data. The model predicted a 69.3% decrease in ABT-384 clearance and 91.1% increase in the volume of distribution of ABT-384 in the presence of ketoconazole. A-1331480 was shown to be formation rate-limited and A-847082 was elimination rate-limited. Both metabolites were characterized by 1-compartment model with first-order rate constants of formation and elimination. Overall the model adequately captured the concentration-time profiles of ABT-384, A-1331480 and A-847082 in both ABT-384 alone and ketoconazole co-administration conditions. Although ABT-384 exposures were greatly increased in the presence of ketoconazole, co-administration of ABT-384 with ketoconazole or other strong/moderate CYP3A inhibitors is not expected to contribute to any major clinical safety issues considering the favorable safety profile of ABT-384.
    Drug metabolism and disposition: the biological fate of chemicals 02/2013; 41(5). DOI:10.1124/dmd.112.049742 · 3.25 Impact Factor

Publication Stats

2k Citations
666.43 Total Impact Points


  • 1994-2011
    • Abbott Laboratories
      • Abbott Laboratories
      North Chicago, Illinois, United States
  • 2009
    • Yonsei University
      • Department of Radiation Oncology
      Sŏul, Seoul, South Korea
  • 2008
    • Bureau of Materials & Physical Research
      Springfield, Illinois, United States
  • 1990-1993
    • University of Minnesota Duluth
      • College of Pharmacy
      Duluth, Minnesota, United States
  • 1987-1993
    • Hennepin County Medical Center
      • Department of Emergency Medicine
      Minneapolis, Minnesota, United States