A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
An Open-Label, Phase 1 Study to Investigate the Comparability of the Pharmacokinetics of Olomorasib (LY3537982) Between Two Capsule Formulations and to Evaluate the Food Effect in Healthy Japanese Participants
Sponsor: Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
Time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)
PK: Area under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib
Time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)
Eligibility Criteria
Inclusion Criteria: * Japanese participants who are overtly healthy as determined by medical evaluation including medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations. * Have a body mass index within the range 18.5 to 30.0 kilograms per square meter (kg/m²), inclusive, at screening. * Participants assigned male at birth (AMAB) may participate in this study. Exclusion Criteria: * Have a history of malignancy within 5 years prior to screening except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years. * Have known allergies to olomorasib or any component of the formulation, or related compounds. * Use of any other investigational drug or device within 30 days or 5 half-lives (if known), whichever is longer, of the first dose of study drug. * Have previously completed or withdrawn from this study or any other st…
Read full criteria on CT.gov →✦ Analyst Commentary
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