A Study of LY3006072 in Healthy Participants

Study Results

Results available

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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

2012-07-24

Study Completion Date

2012-11-26

Brief Summary

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The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

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Detailed Description

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This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules administered orally

LY3006072

Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.

Group Type EXPERIMENTAL

LY3006072

Intervention Type DRUG

Capsules administered orally

Interventions

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Placebo

Capsules administered orally

Intervention Type DRUG

LY3006072

Capsules administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females, as determined by medical history and physical examination
* Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
* Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
* Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m\^2), inclusive

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes