A Study of LY3873862 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492201
• Other study ID #: 18445
• Secondary ID: J3X-MC-LYGA2022-
• Status: Recruiting
• Phase: Phase 1
• Start date: August 11, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3873862
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 72 days
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3873862	PK: AUC[0-8] of LY3873862	Predose up to 96 hours postdose
Secondary	PK: Area Under the Concentration versus Time Curve at Steady State (AUCt) of LY3873862	PK: (AUCt) of LY3873862	Predose up to 96 hours postdose
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3873862	PK: Cmax of LY3873862	Predose up to 96 hours postdose
Secondary	PK: Time of Maximum observed Concentration (Tmax) of LY3873862	PK: Tmax of LY3873862	Predose up to 96 hours postdose