A Study of Single and Repeated Doses of LY3556050 in Healthy Participants

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-14

Study Completion Date

2017-06-02

Brief Summary

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The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.

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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

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

All the participants will be double blinded except for LY3556050 (Part 1) - Cohort 7 which will be open label.

Study Groups

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LY3556050 (Part 1)

Participants will receive single ascending doses of LY3556050 orally.

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Placebo (Part 1)

Participants will receive placebo orally.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered orally.

LY3556050 (Part 2)

Participants will receive multiple ascending doses of LY3556050 orally.

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Placebo (Part 2)

Participants will receive placebo orally.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3556050

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Other Intervention Names

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CNTX-0290

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy as determined by medical evaluation.
* Participants with a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²) and have body weight of 50 kg or more.

Exclusion Criteria

* Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on Electrocardiogram (ECG).
* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy.
* Has asthma or other severe respiratory disease.
* Is pregnant, lactating, or planning a pregnancy.
* Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization.
* Any abnormal laboratory finding or vital signs outside specified parameters.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes