A Safety Study of LY2811376 Single Doses in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety Study of LY2886721 Single Doses in Healthy Subjects

NCT01133405

Alzheimer's Disease

COMPLETED PHASE1

A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

NCT01227252

Alzheimer's Disease

COMPLETED PHASE1

A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

NCT01807026

Alzheimer Disease Healthy Volunteers

COMPLETED PHASE1

A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)

NCT03720548

Alzheimer Disease

COMPLETED PHASE1

A Study of LY3002813 in Participants With Alzheimer's Disease

NCT01837641

Alzheimer Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 LY2811376 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 a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY2811376 Part 1

LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.

Group Type EXPERIMENTAL

LY2811376

Intervention Type DRUG

Oral capsules

Placebo Part 1

once a day or twice a day for 1 day in up to 3 periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsules

LY2811376 - Part 2 low dose

Single dose of LY2811376, dose determined by part 1

Group Type EXPERIMENTAL

LY2811376

Intervention Type DRUG

Oral capsules

LY2811376 - Part 2 high dose

Single dose of LY2811376, dose determined by part 1

Group Type EXPERIMENTAL

LY2811376

Intervention Type DRUG

Oral capsules

Placebo Part 2

single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY2811376

Oral capsules

Intervention Type DRUG

Placebo

Oral capsules

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy men and nonchild-bearing potential women
* 20 years or older
* Body mass index between 18-32kg/m2

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.
* Consume more than 5 cups of coffee per day.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes