Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rifampicin Oral Capsule; Drug: Itraconazole oral solution; Drug: Olorofim

• Registration Number: NCT04171739
• Lead Sponsor: F2G Biotech GmbH

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-18
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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/m2.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Olorofim	Itraconazole DDI
Cohort B	Rifampicin Oral Capsule	Rifampicin DDI
Cohort A	Itraconazole oral solution	Itraconazole DDI
Cohort B	Olorofim	Rifampicin DDI

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.	16 days
maximum plasma concentration (Cmax) for olorofim.	16 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom