A Study of LY3873862 in Healthy Participants
Study Details
Study Description
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 non-Japanese and Japanese 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 40 and 58 days for part A and B, respectively.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3873862 (Part A) LY3873862 administered orally as single dose. |
Drug: LY3873862
Administered orally.
|
| Placebo Comparator: Placebo (Part A) Placebo administered orally. |
Drug: Placebo
Administered orally.
|
| Experimental: LY3873862 (Part B) LY3873862 administered orally as multiple doses. |
Drug: LY3873862
Administered orally.
|
| Placebo Comparator: Placebo (Part B) Placebo administered orally. |
Drug: Placebo
Administered orally.
|
Outcome Measures
Primary Outcome Measures
- 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 98 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
- 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
Eligibility Criteria
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
-
For Part B, first-generation Japanese participants who are of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hammersmith Medicines Research | London | United Kingdom | NW10 7EW |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18445
- J3X-MC-LYGA
- 2022-000500-36