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

NCT05341102 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18327J2P-MC-LXBB
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

  A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 30

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)

  PK: 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: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1)

  PK: 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: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)

  PK: fe\[0-48\] of LY3556050 (Part 1)

  Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)

• PK: Cmax of LY3556050 (Part 2)

  PK: Cmax of LY3556050 (Part 2)

  Predose up to Postdose on Day 10

• PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2)

  PK: AUC\[0-24\] of LY3556050 (Part 2)

  Predose up to Postdose on Day 10

Study Arms (4)

LY3556050 (Part 1)

EXPERIMENTAL

Participants will receive single ascending doses of LY3556050 orally.

Drug: LY3556050

Placebo (Part 1)

EXPERIMENTAL

Participants will receive placebo orally.

Drug: Placebo

LY3556050 (Part 2)

EXPERIMENTAL

Participants will receive multiple ascending doses of LY3556050 orally.

Drug: LY3556050

Placebo (Part 2)

EXPERIMENTAL

Participants will receive placebo orally.

Drug: Placebo

Interventions

LY3556050 DRUG

Administered orally.

Also known as: CNTX-0290

LY3556050 (Part 1); LY3556050 (Part 2)

Placebo DRUG

Administered orally.

Placebo (Part 1); Placebo (Part 2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Medpace Clinical Pharmacology, LLC

Cincinnati, Ohio, 45227, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All the participants will be double blinded except for LY3556050 (Part 1) - Cohort 7 which will be open label.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: September 14, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)