Jeff Suico

Eli Lilly and Company

Purpose Crenigacestat (LY3039478) is a Notch inhibitor currently being investigated in advanced cancer patients. Conducting clinical pharmacology studies in healthy subjects avoids nonbeneficial drug exposures in cancer patients and mitigates confounding effects of disease state and concomitant medications. Methods Three studies were conducted in...

Nasal Glucagon: Potentially Viable Alternative to Treat Insulin- Induced Hypoglycemia in Adults with Type 1 Diabetes JEFFREY SUICO, ULRIKE HÖVELMANN, SHUYU ZHANG, TONG SHEN, BRANDON BERGMAN, JENNIFER SHERR, ERIC ZIJLSTRA, BRIAN FRIER, LEONA PLUM-MORSCHEL Indianapolis, Indiana, USA Mainz, Germany Edinburgh, UK Commercially available glucagon require...

Aim: Evaluate steady-state pharmacokinetics and potential interactions between select statins and evacetrapib. Patients & methods: This open-label, two-part study included 62 healthy native Chinese subjects. Part 1 evaluated pharmacokinetics and pharmacodynamics of evacetrapib after 1 or 14 once-daily doses. Part 2 evaluated pharmacokinetics and ph...

Background: LY3039478 is an oral Notch inhibitor that prevents release of the Notch Intracellular Domain (NICD) by inhibiting proteolytic activity of the gamma (γ)-secretase complex. LY3039478 also inhibits production of plasma amyloid-beta (Aβ), which can be used as a biomarker to determine pharmacodynamic (PD) effects of LY3039478. Covariates aff...

Background: LY3039478 is an oral, potent small-molecule Notch inhibitor being investigated for the treatment of advanced cancers. The effect of single doses on corrected QT interval, absolute and relative bioavailability were explored in three studies (Table 1). These studies were conducted in healthy subjects to mitigate the confounding effects of...

The safety, pharmacokinetic, and pharmacodynamic effects of LY2584702, a selective inhibitor for p70 S6 serine/threonine protein kinase-1, were evaluated in healthy dyslipidemic volunteers. LY2584702 was tolerated well as a monotherapy and dose-dependently reduced low-density lipoprotein cholesterol and triglycerides by up to 60% and 50%, respectiv...

Table S1. Causes of Achlorhydria

Study objective: To examine the effect of increased gastric pH on exposure to evacetrapib, a cholesteryl ester transfer protein inhibitor evaluated for the treatment of atherosclerotic heart disease. Design: Open-label, two-treatment, two-period, fixed-sequence, crossover study. Setting: Clinical research unit. Subjects: Thirty-four healthy...

Purpose: The aim of this study is to investigate the effect of hepatic or renal impairment on the pharmacokinetics of a single 130-mg evacetrapib dose. Methods: Two open-label, parallel-design studies in males and females with normal hepatic function or Child-Pugh mild, moderate, or severe hepatic impairment, or with normal renal function or sev...

This open-label, single-period study in healthy subjects estimated evacetrapib absolute bioavailability following simultaneous administration of a 130-mg evacetrapib oral dose and 4-h intravenous (IV) infusion of 175 µg [(13) C8 ]-evacetrapib as a tracer. Plasma samples collected through 168 h were analyzed for evacetrapib and [(13) C8 ]-evacetrapi...

Figure S2. Phase 1 drug–drug interaction study with gemfibrozil in healthy subjects.

Figure S1. Phase 1 drug–drug interaction study with ketoconazole in healthy subjects.

Evacetrapib is an investigational cholesteryl ester transfer protein inhibitor (CETPi) for reduction of risk of major adverse cardiovascular events in patients with high-risk vascular disease. Understanding evacetrapib disposition, metabolism, and the potential for drug–drug interactions (DDI) may help guide prescribing recommendations. In vitro, e...

AimsEvacetrapib is a cholesteryl ester transfer protein (CETP) inhibitor under development for reducing cardiovascular events in patients with high-risk vascular disease. CETP inhibitors are likely to be utilised as “add-on” therapy to statins in patients receiving concomitant medications, so the potential for evacetrapib to cause clinically import...

To determine the effect of a high-fat meal on evacetrapib exposure at steady state in healthy participants. This was a randomized, 2-period, 2-sequence, open-label, crossover study. Patients were randomly assigned to 1 of the 2 treatment sequences in which they received evacetrapib 130 mg/d for 10 days following a 10-hour fast each day or following...

Objectives We investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of evacetrapib.Methods Healthy volunteers received multiple daily doses of evacetrapib (10–600 mg) administered for up to 15 days in a placebo-controlled study.Key findingsMean peak plasma concentrations of evacetrapib occurred at 4–6 h and terminal half-life...

Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression. The kappa opioid receptor antagonist, LY2456302, exhibits ~30-fold higher affinity for kappa opioid receptors over mu opioid receptors, which is the next closest identified pharmacology. Here, we determined kappa opioid receptor pharmaco...

Purpose:To evaluate whether evacetrapib prolongs QT intervals in healthy participants. This was a single-center, randomized, active and placebo-controlled, 3-period, 6-sequence, and crossover study. Participants were randomized to 1 of 6 treatment sequences in which they received 1 of 3 treatments: evacetrapib 1200 mg daily for 10 days (supratherap...

Background Pharmacodynamic effects of opiate antagonists and agonists such as naltrexone (NTX) and fentanyl (FE) have been documented in separate studies and various populations. However, no data are available for a direct comparison in the same group of subjects.MethodsNTX 50mg QD and a matched placebo were compared in a randomized double-blind cr...

The Logical Observation Identifier Names and Codes (LOINC) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical...

Electronic laboratory reporting can improve surveillance for notifiable conditions. Building on standards for message structure and content, we have implemented an electronic laboratory reporting system by building on the infrastructure created for the Indiana Network for Patient Care (INPC). The system has proven reliable in delivering results and...

[McDonald CJ, Schadow G, Suico J, Overhage JM. Data standards in health care. Ann Emerg Med. September 2001;38:303-311.]

The Regenstrief Medical Record System (RMRS) continues to grow in breadth and depth. As we expand its breadth -- the system links 5 health care systems, 11 acute care hospitals, 13 homeless care sites, nearly 100 clinics/offices and the county and state health departments -- we have had to overcome critical problems inherent to creating a community...

Entrusted with the records for more than 1.5 million patients, the Regenstrief Medical Record System (RMRS) has evolved into a fast and comprehensive data repository used extensively at three hospitals on the Indiana University Medical Center campus and more than 30 Indianapolis clinics. The RMRS routinely captures laboratory results, narrative rep...

The authors surveyed existing standard codes for units of measures, such as ISO 2955, ANSI X3.50, and Health Level 7's ISO+. Because these standards specify only the character representation of units, the authors developed a semantic model for units based on dimensional analysis. Through this model, conversion between units and calculations with di...

The rain forest canopy is a seamless web through which arboreal creatures efficiently move to reach the edible fruits without any attention to the individual trees. Individual health care computer systems are rich with patient data, but rather than a canopy linking all the trees in the forest, the data "fruit" come from a diverse forest of individu...

The rain forest canopy is a seamless web through which arboreal creatures efficiently move to reach the edible fruits without any atttention to the individual trees. Individual health care computer systems are rich with patient data, but rather than a canopy linking all the trees in the forest, the data "fruit" come from a diverse forest of individ...

Associations between specific foot-care behaviors and foot lesions in patients with non-insulin-dependent diabetes mellitus were prospectively investigated. Data from a randomized controlled trial for preventing diabetic foot lesions were analyzed as a prospective cohort using logistic regression. Independent variables included foot-care behaviors,...

Medical informatic experts have made considerable progress in the development of standards for orders and clinical results (CEN, HL7, ASTM), EKG tracings (CEN), diagnostic images (DICOM), claims processing (X12 and EDIFAC) and in vocabulary and codes (SNOMED, Read Codes, the MED, LOINC). Considerable work still remains to be carried out. Abstract m...

We introduce the concept of a Medical Informatics Workup performed by fourth year medical students working in a busy inner-city Emergency Room. These students use portable computers (Macintosh PowerBook 170s connected to a removable cartridge hard drive and CD-ROM drive) to do the patient workups. The PowerBook 170 contains the automated medical re...