A Study of LY2886721 in Healthy Participants

NCT ID: NCT01534273

Last Updated: 2019-08-28

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

35 mg LY2886721

QD oral dosing for 14 consecutive days

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Administered orally.

70 mg LY2886721

Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Administered orally.

140 mg LY2886721

Single oral dose

Group Type EXPERIMENTAL

LY2886721

Intervention Type DRUG

Administered orally.

Interventions

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LY2886721

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and non-childbearing potential women
* Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2)
* Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals
* Smoke more than 10 cigarettes per day
* Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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I4O-MC-BACJ

Identifier Type: OTHER

Identifier Source: secondary_id

14464

Identifier Type: -

Identifier Source: org_study_id

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