A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of 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

2019-12-05

Study Completion Date

2020-09-15

Brief Summary

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This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as intact tablets and via NG tube

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IV

2 h IV infusion (Groups A/B)

Group Type OTHER

Olorofim

Intervention Type DRUG

150 mg

oral (fasted)

30 mg tablets given after an overnight fast (Groups A/B)

Group Type OTHER

Olorofim

Intervention Type DRUG

150 mg

oral (fed)

30 mg tablets given after a high fat breakfast (Groups A/B)

Group Type OTHER

Olorofim

Intervention Type DRUG

150 mg

oral (intact tablet)

30 mg tablets (Group C)

Group Type OTHER

Olorofim

Intervention Type DRUG

150 mg

oral (NG tube)

30 mg tablets in water via NG tube (Group C)

Group Type OTHER

Olorofim

Intervention Type DRUG

150 mg

Interventions

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Olorofim

150 mg

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 30 kg/m2.
* subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria

* 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