A Study of LY3873862 in Healthy Participants
- Registration Number
- NCT05492201
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3873862 (Part C) LY3873862 LY3873862 administered orally as multiple doses. Placebo (Part A) Placebo Placebo administered orally. LY3873862 (Part A) LY3873862 LY3873862 administered orally as single dose. Placebo (Part B) Placebo Placebo administered orally. Placebo (Part C) Placebo Placebo administered orally. LY3873862 (Part B) LY3873862 LY3873862 administered orally as multiple doses.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862 Predose up to 96 hours postdose PK: AUC\[0-∞\] of LY3873862
PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862 Predose up to 96 hours postdose PK: (AUCτ) of LY3873862
PK: Maximum Observed Concentration (Cmax) of LY3873862 Predose up to 96 hours postdose PK: Cmax of LY3873862
PK: Time of Maximum observed Concentration (Tmax) of LY3873862 Predose up to 96 hours postdose PK: Tmax of LY3873862
Trial Locations
- Locations (1)
Hammersmith Medicines Research
🇬🇧London, United Kingdom