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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2020-02-11

Brief Summary

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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 .

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort A

Itraconazole DDI

Group Type OTHER

Itraconazole oral solution

Intervention Type DRUG

200 mg once daily on Days 6 to 15

Olorofim

Intervention Type DRUG

Single oral dose on Days 1 and 11

Cohort B

Rifampicin DDI

Group Type OTHER

Rifampicin Oral Capsule

Intervention Type DRUG

600 mg once daily on Days 6 to 15

Olorofim

Intervention Type DRUG

Single oral dose on Days 1 and 11

Interventions

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Itraconazole oral solution

200 mg once daily on Days 6 to 15

Intervention Type DRUG

Rifampicin Oral Capsule

600 mg once daily on Days 6 to 15

Intervention Type DRUG

Olorofim

Single oral dose on Days 1 and 11

Intervention Type DRUG

Other Intervention Names

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F901318

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes