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OpenTrials
Completed

NCT Number: NCT07044271

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, San Antonio, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olomorasib

Drug

Single dose

Other names: LY3537982

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib

    Time frame: From Day 1, Predose up to 72 hours Postdose

    PK: AUC(0-tlast) of Olomorasib

  2. PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib

    Time frame: From Day 1, Predose up to 72 hours Postdose

    PK: AUC(0-∞) of Olomorasib

  3. PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib

    Time frame: From Day 1, Predose up to 72 hours Postdose

    PK: Cmax of Olomorasib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-Label, Randomized, 3-Way Crossover Study Comparing the Pharmacokinetics of Multiple Olomorasib (LY3537982) Capsules

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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