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OpenTrials
Completed

NCT Number: NCT05341102

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

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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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology, LLC

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3556050

Drug

Administered orally.

Other names: CNTX-0290

Placebo

Drug

Administered orally.

Primary outcomes

  1. 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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  5. PK: Cmax of LY3556050 (Part 2)

    Time frame: Predose up to Postdose on Day 10

    PK: Cmax of LY3556050 (Part 2)

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

    Time frame: Predose up to Postdose on Day 10

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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