NCT04171739
Completed
Phase 1
A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose of Olorofim.
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Olorofim
- Conditions
- Healthy
- Sponsor
- F2G Biotech GmbH
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.
Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .
Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
Investigators
Eligibility Criteria
Inclusion Criteria
- •males or females of any ethnic origin between 18 and 55 years of age
- •subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 32 kg/m
- •subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Exclusion Criteria
- •Female subjects of child-bearing potential.
- •Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- •Female subjects who are pregnant or lactating.
- •Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
- •Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
- •Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
- •Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
Arms & Interventions
Cohort B
Rifampicin DDI
Intervention: Olorofim
Cohort A
Itraconazole DDI
Intervention: Itraconazole oral solution
Cohort A
Itraconazole DDI
Intervention: Olorofim
Cohort B
Rifampicin DDI
Intervention: Rifampicin Oral Capsule
Outcomes
Primary Outcomes
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
Time Frame: 16 days
maximum plasma concentration (Cmax) for olorofim.
Time Frame: 16 days
Secondary Outcomes
- terminal elimination half-life (t½) for olorofim(16 days)
- area under the concentration-time curve to infinity (AUC0-∞) for olorofim(16 days)
- Number of subjects with treatment-related adverse events(23 days)
- Time to Cmax (Tmax) of olorofim(16 days)
Study Sites (1)
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