A Study of LY2409021 Formulations in Healthy Participants

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: LY2409021

• Registration Number: NCT02385084
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2018-03
• Results First Submitted: 2018-03-24
• Results First Submitted QC: 2018-03-24
• Last Update Submitted: 2018-03-24
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)
• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

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Exclusion Criteria

• Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have known or ongoing psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: LY2409021 Tablet Pre-commercial	LY2409021	Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.
Part B: LY2409021 Capsule	LY2409021	Single oral dose of LY2409021 capsule in one of two study periods.
Part B: LY2409021 Tablet Commercial	LY2409021	Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.
Part A: LY2409021 Tablet Commercial	LY2409021	Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.
Part A: LY2409021 Capsule	LY2409021	Single oral dose of LY2409021 capsule in one of three study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021	Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
PK: Maximum Plasma Concentration (Cmax) of LY2409021	Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period

Trial Locations

Locations (1)

Covance CRU, Inc; 🇺🇸 Daytona Beach, Florida, United States