A Study of LY2409021 Formulations in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A: LY2409021 Capsule

Single oral dose of LY2409021 capsule in one of three study periods.

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally

Part A: LY2409021 Tablet Pre-commercial

Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally

Part A: LY2409021 Tablet Commercial

Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally

Part B: LY2409021 Capsule

Single oral dose of LY2409021 capsule in one of two study periods.

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally

Part B: LY2409021 Tablet Commercial

Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally

Interventions

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LY2409021

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes