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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3556050; Drug: Placebo

• Registration Number: NCT05341102
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-14
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Status Verified: 2022-04
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3556050 (Part 2)	LY3556050	Participants will receive multiple ascending doses of LY3556050 orally.
Placebo (Part 1)	Placebo	Participants will receive placebo orally.
LY3556050 (Part 1)	LY3556050	Participants will receive single ascending doses of LY3556050 orally.
Placebo (Part 2)	Placebo	Participants will receive placebo orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 30	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)	Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)	PK: Cmax of LY3556050 (Part 1)
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1)	Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)	PK: AUC\[0-∞\] of LY3556050 (Part 1)
PK: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)	Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)	PK: fe\[0-48\] of LY3556050 (Part 1)
PK: Cmax of LY3556050 (Part 2)	Predose up to Postdose on Day 10	PK: Cmax of LY3556050 (Part 2)
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2)	Predose up to Postdose on Day 10	PK: AUC\[0-24\] of LY3556050 (Part 2)

Trial Locations

Locations (1)

Medpace Clinical Pharmacology, LLC; 🇺🇸 Cincinnati, Ohio, United States