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

Sponsor
F2G Ltd
Study ID
NCT04207957
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 5, 2019
Status verified
Jan 2021
Primary completion
Sep 15, 2020
Completion
Sep 15, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: IV
    2 h IV infusion (Groups A/B)
  • Other: oral (fasted)
    30 mg tablets given after an overnight fast (Groups A/B)
  • Other: oral (fed)
    30 mg tablets given after a high fat breakfast (Groups A/B)
  • Other: oral (intact tablet)
    30 mg tablets (Group C)
  • Other: oral (NG tube)
    30 mg tablets in water via NG tube (Group C)

Primary Outcome Measure

maximum plasma concentration (Cmax) for olorofim [ Time Frame: 35 days ]

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