Healthy japanese volunteers test how food affects new drug absorption
NCT ID NCT07124013
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two different capsule forms of the drug olomorasib are absorbed into the blood, and whether food changes that absorption. It involved 191 healthy Japanese participants over about 6 weeks. The goal was to gather information, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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191 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 study investigating olomorasib and have previously received olomorasib * Show evidence of hepatitis B or positive hepatitis B surface antigen. * Show evidence of hepatitis C or have a positive hepatitis C virus antibody test. * Show evidence of HIV infection or positive HIV antigen or HIV antibodies. * Show evidence of syphilis or have a positive syphilis test.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Souseikai Fukuoka Mirai Hospital
Fukuoka, 813-0017, Japan
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