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Completed

NCT Number: NCT04207957

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Leeds, West Yorkshire, LS2 9LH, 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 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

Treatment and study plan

olorofim

Drug

150 mg

Other names: F901318

Primary outcomes

  1. maximum plasma concentration (Cmax) for olorofim

    Time frame: 35 days

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

    Time frame: 35 days

  3. Absolute bioavailability of olorofim (F)

    Time frame: 35 days

Secondary outcomes

  1. Time to Cmax (TMax) for olorofim

    Time frame: 35 days

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

    Time frame: 35 days

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

    Time frame: 35 days

  4. Number of subjects with treatment-related adverse events

    Time frame: 35 days

Sponsors and collaborators

Lead sponsor

F2G Ltd

Industry

Collaborators

  • Covance

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Jan 8, 2021

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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