Clinical trial NCT04207957: A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
Official title: A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: F2G Biotech GmbH
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2019-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C
Primary purpose: OTHER

Brief summary: 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


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 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

Primary outcomes:
measure: maximum plasma concentration (Cmax) for olorofim
timeFrame: 35 days
measure: area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim
timeFrame: 35 days
measure: Absolute bioavailability of olorofim (F)
timeFrame: 35 days
Secondary outcomes:
measure: Time to Cmax (TMax) for olorofim
timeFrame: 35 days
measure: area under the concentration time curve to infinity (AUC0-∞) for olorofim
timeFrame: 35 days
measure: terminal elimination half-life (t½) for olorofim
timeFrame: 35 days
measure: Number of subjects with treatment-related adverse events
timeFrame: 35 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
state: West Yorkshire
Study officials:
affiliation: Covance CRU
name: Jim Bush, MBChB
role: PRINCIPAL_INVESTIGATOR
References: