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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Olomorasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07044271

27282

J3M-OX-JZQK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Olomorasib - (Test Formulation 1)

Experimental group

Description:

Olomorasib administered orally

Treatment:

Drug: Olomorasib

Olomorasib - (Test Formulation 2)

Experimental group

Description:

Olomorasib administered orally

Treatment:

Drug: Olomorasib

Olomorasib - (Reference Formulation)

Active Comparator group

Description:

Olomorasib administered orally

Treatment:

Drug: Olomorasib