Clinical trial NCT05492201: A Study of LY3873862 in Healthy Participants
Official title: A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
* Are male or female participants, including those of childbearing potential

Exclusion Criteria:

* Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
* Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A4. The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.

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 72 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862
timeFrame: Predose up to 96 hours postdose
measure: PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862
timeFrame: Predose up to 96 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3873862
timeFrame: Predose up to 96 hours postdose
measure: PK: Time of Maximum observed Concentration (Tmax) of LY3873862
timeFrame: Predose up to 96 hours postdose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
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: