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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341102
• Other study ID #: 18327
• Secondary ID: J2P-MC-LXBB
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: April 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3556050
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology, LLC	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3556050 (Part 1)	PK: AUC[0-8] 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)
Primary	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)
Primary	PK: Cmax of LY3556050 (Part 2)	PK: Cmax of LY3556050 (Part 2)	Predose up to Postdose on Day 10
Primary	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