A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)3A
- •The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.
Arms & Interventions
LY3873862 (Part A)
LY3873862 administered orally as single dose.
Intervention: LY3873862 (Drug)
Placebo (Part A)
Placebo administered orally.
Intervention: Placebo (Drug)
LY3873862 (Part B)
LY3873862 administered orally as multiple doses.
Intervention: LY3873862 (Drug)
Placebo (Part B)
Placebo administered orally.
Intervention: Placebo (Drug)
LY3873862 (Part C)
LY3873862 administered orally as multiple doses.
Intervention: LY3873862 (Drug)
Placebo (Part C)
Placebo administered orally.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 72 days
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862(Predose up to 96 hours postdose)
- PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862(Predose up to 96 hours postdose)
- PK: Maximum Observed Concentration (Cmax) of LY3873862(Predose up to 96 hours postdose)
- PK: Time of Maximum observed Concentration (Tmax) of LY3873862(Predose up to 96 hours postdose)