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

Sponsor
F2G Biotech GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04171739
Collaborator
Hammersmith Medicines Research (Other)
24
Enrollment
1
Location
2
Arms
2.8
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: Itraconazole oral solution
  • Drug: Rifampicin Oral Capsule
  • Drug: Olorofim
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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.
Actual Study Start Date :
Nov 18, 2019
Actual Primary Completion Date :
Feb 11, 2020
Actual Study Completion Date :
Feb 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Cohort A

Itraconazole DDI

Drug: Itraconazole oral solution
200 mg once daily on Days 6 to 15

Drug: Olorofim
Single oral dose on Days 1 and 11
Other Names:
  • F901318

    		•
    Other: Cohort B

    Rifampicin DDI

    Drug: Rifampicin Oral Capsule
    600 mg once daily on Days 6 to 15

    Drug: Olorofim
    Single oral dose on Days 1 and 11
    Other Names:
  • F901318

    		•

    Outcome Measures

    Primary Outcome Measures

    1. maximum plasma concentration (Cmax) for olorofim. [16 days]

    2. Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim. [16 days]

    Secondary Outcome Measures

    1. Time to Cmax (Tmax) of olorofim [16 days]

    2. area under the concentration-time curve to infinity (AUC0-∞) for olorofim [16 days]

    3. terminal elimination half-life (t½) for olorofim [16 days]

    4. Number of subjects with treatment-related adverse events [23 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hammersmith Medicines Research London United Kingdom NW10 7EW

    Sponsors and Collaborators

    • F2G Biotech GmbH
    • Hammersmith Medicines Research

    Investigators

    • Principal Investigator: Adeep Puri, Hammersmith Medicines Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    F2G Biotech GmbH
    ClinicalTrials.gov Identifier:
    NCT04171739
    Other Study ID Numbers:
    • F901318-01-15
    First Posted:
    Nov 21, 2019
    Last Update Posted:
    Jul 24, 2020
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Itraconazole
    Olorofim
    Rifampin

    Study Results

    No Results Posted as of Jul 24, 2020