A Phase 1 Study of Olorofim in Healthy Japanese and Caucasian Participants

JRCT ID: jRCT2031230016

Registered date:10/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult participants
• Date of first enrollment: 27/03/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Oral administration of olorofim (F901318)

Outcome(s)

• Primary Outcome: Primary PK parameters: Cmax and AUC0-last for olorofim.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

-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

Exclude criteria

-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

Related Information

• Primary Sponsor: Nagata Tsutae