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

Sponsor
F2G Ltd
Study ID
NCT04171739
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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 .

Key Dates

First listed
Nov 21, 2019
Start date
Nov 18, 2019
Status verified
Nov 2019
Primary completion
Feb 11, 2020
Completion
Feb 11, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Cohort A
    Itraconazole DDI
  • Other: Cohort B
    Rifampicin DDI

Primary Outcome Measure

maximum plasma concentration (Cmax) for olorofim. [ Time Frame: 16 days ]

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