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

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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