Clinical trial NCT05341102: A Study of Single and Repeated Doses of LY3556050 in Healthy Participants
Official title: A Study to Evaluate the Safety and Pharmacokinetics of Single and Repeated Doses of CNTX-0290 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline through Day 30
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)
timeFrame: Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
measure: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1)
timeFrame: Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)
measure: PK: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)
timeFrame: Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)
measure: PK: Cmax of LY3556050 (Part 2)
timeFrame: Predose up to Postdose on Day 10
measure: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2)
timeFrame: Predose up to Postdose on Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology, LLC
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: