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

A Study to Evaluate the Safety and Pharmacokinetics of Single and Repeated Doses of CNTX-0290 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3556050

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3556050 (Part 1); Participants will receive single ascending doses of LY3556050 orally.	Drug: LY3556050; Administered orally.; Other Names: CNTX-0290
EXPERIMENTAL: Placebo (Part 1); Participants will receive placebo orally.	Drug: Placebo; Administered orally.
EXPERIMENTAL: LY3556050 (Part 2); Participants will receive multiple ascending doses of LY3556050 orally.	Drug: LY3556050; Administered orally.; Other Names: CNTX-0290
EXPERIMENTAL: Placebo (Part 2); Participants will receive placebo orally.	Drug: Placebo; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2016
• Primary Completion (ACTUAL): June 2, 2017
• Study Completion (ACTUAL): June 2, 2017

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18327 (Other Identifier: City of Hope Comprehensive Cancer Center); J2P-MC-LXBB (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes