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Completed

NCT Number: NCT04171739

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itraconazole oral solution

Drug

200 mg once daily on Days 6 to 15

Rifampicin Oral Capsule

Drug

600 mg once daily on Days 6 to 15

olorofim

Drug

Single oral dose on Days 1 and 11

Other names: F901318

Primary outcomes

  1. maximum plasma concentration (Cmax) for olorofim.

    Time frame: 16 days

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

    Time frame: 16 days

Secondary outcomes

  1. Time to Cmax (Tmax) of olorofim

    Time frame: 16 days

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

    Time frame: 16 days

  3. terminal elimination half-life (t½) for olorofim

    Time frame: 16 days

  4. Number of subjects with treatment-related adverse events

    Time frame: 23 days

Sponsors and collaborators

Lead sponsor

F2G Ltd

Industry

Collaborators

  • Hammersmith Medicines Research

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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