A Phase 1 Study of Olorofim in Healthy Japanese and Caucasian Participants
- Conditions
- Healthy adult participants
- Registration Number
- JPRN-jRCT2031230016
- Lead Sponsor
- agata Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Participants between ages of 18 and 55 years (inclusive) at the time of signing informed consent
-Participants must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations at screening and the day before administration of study intervention (Day-1)
-Japanese or Caucasian
-Male or female participant
-Participants have had surgery that may affect drug absorption, distribution, metabolism, or excretion
-Participants with, or with a history of, any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking olorofim; or interfering with the interpretation of data
-Participants with resting systolic blood pressure (BP) outside the range of 90 to 140 mmHg, resting diastolic BP outside the range of 60 to 90 mmHg, or pulse rate outside the range of 50 to 100 bpm at screening or Day 1 predose, and considered ineligible by the investigator
-Participants who have hypersensitivity to any of the study interventions or components thereof, or drug or any other clinically significant allergy as considered ineligible by the investigator (excluding mild or seasonal allergies such as contact dermatitis or hay fever)
-Participants who had any malignancy (including lymphoma, leukemia) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
-Participants with any clinically relevant history of convulsion (other than childhood febrile convulsion before the age of 6 years), syncope, hypotension, dizziness, and fainting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary PK parameters: Cmax and AUC0-last for olorofim.
- Secondary Outcome Measures
Name Time Method