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

NCT04171739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-24

No results posted yet for this study

Summary

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 .

Conditions

  • Healthy

Interventions

DRUG

Itraconazole oral solution

200 mg once daily on Days 6 to 15

DRUG

Rifampicin Oral Capsule

600 mg once daily on Days 6 to 15

DRUG

Olorofim

Single oral dose on Days 1 and 11

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Adeep Puri · Hammersmith Medicines Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2020-02-11
Completion
2020-02-11

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171739 on ClinicalTrials.gov