A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Olomorasib

• Registration Number: NCT07044271
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-01
• Primary Completion: 2025-09
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
• Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
• Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).

Exclusion Criteria

• Females who are lactating or of childbearing potential
• Clinically significant history of any drug sensitivity, drug allergy, or food allergy
• Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olomorasib - (Test Formulation 1)	Olomorasib	Olomorasib administered orally
Olomorasib - (Test Formulation 2)	Olomorasib	Olomorasib administered orally
Olomorasib - (Reference Formulation)	Olomorasib	Olomorasib administered orally

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib	From Day 1, Predose up to 72 hours Postdose	PK: AUC(0-tlast) of Olomorasib
PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib	From Day 1, Predose up to 72 hours Postdose	PK: AUC(0-∞) of Olomorasib
PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib	From Day 1, Predose up to 72 hours Postdose	PK: Cmax of Olomorasib

Trial Locations

Locations (2)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States

ICON; 🇺🇸 Salt Lake City, Utah, United States