NCT04171739

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

July 24, 2020

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 19, 2019

Last Update Submit

July 23, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • maximum plasma concentration (Cmax) for olorofim.

    16 days

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

    16 days

Secondary Outcomes (4)

  • Time to Cmax (Tmax) of olorofim

    16 days

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

    16 days

  • terminal elimination half-life (t½) for olorofim

    16 days

  • Number of subjects with treatment-related adverse events

    23 days

Study Arms (2)

Cohort A

OTHER

Itraconazole DDI

Drug: Itraconazole oral solutionDrug: Olorofim

Cohort B

OTHER

Rifampicin DDI

Drug: Rifampicin Oral CapsuleDrug: Olorofim

Interventions

Itraconazole oral solutionDRUG

200 mg once daily on Days 6 to 15

Cohort A
Rifampicin Oral CapsuleDRUG

600 mg once daily on Days 6 to 15

Cohort B
OlorofimDRUG

Single oral dose on Days 1 and 11

Also known as: F901318
Cohort ACohort B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 32 kg/m2.
  • subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

You may not qualify if:

  • Female subjects of child-bearing potential.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

ItraconazoleRifampinolorofim

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Adeep Puri

    Hammersmith Medicines Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

November 18, 2019

Primary Completion

February 11, 2020

Study Completion

February 11, 2020

Last Updated

July 24, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)