A Safety Study of LY2886721 Single Doses in Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.

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Detailed Description

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This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. Part 1 will assess the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of an LY2886721 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Conditions

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Alzheimer's Disease

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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LY2886721 Part 1: Cohort A/B

Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Oral capsules

Placebo Part 1: Cohort A/B

Single dose in up to 1 period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsules

LY2886721 Part 2: Cohort C

Single 10 mg dose of LY2886721, dose determined by Part 1

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Oral capsules

LY2886721 Part 2: Cohort D

Single 35 mg dose of LY2886721, dose determined by Part 1

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Oral capsules

Placebo Part 2: Cohort C/D

Single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsules

Interventions

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LY2886721

Oral capsules

Intervention Type DRUG

Placebo

Oral capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and nonchild-bearing potential women
* 20 years or older
* Body mass index between 18-32 kilograms per square meter (kg/m\^2)

Exclusion Criteria

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement
* Smoke more than 10 cigarettes per day

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes