Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe

NCT02680808 | Completed Phase 1

• 1 other identifier: F901318.01.04.15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• area under concentration/time curve

  AUC0-24

  24 hours

Secondary Outcomes (1)

• safety and tolerability as assessed by number of treatment related adverse events

  24 hours

Study Arms (1)

midazolam with F901318

EXPERIMENTAL

Pharmacokinetic profile of midazolam 2 mg orally when given after dosing with F901318 to steady state.

Drug: Midazolam with F901318

Interventions

Midazolam with F901318 DRUG

Pharmacokinetics of midazolam with F901318

midazolam with F901318

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive.
• Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
• Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.

You may not qualify if:

• Male subjects who are not willing to use appropriate contraception during the study and for three months thereafter.
• Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
• Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
• Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety. For at least 2 weeks prior to dosing and until all blood samples and observations are completed on Day 15 +/- 2s, subjects will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family e.g. kale, broccoli, watercress, spring greens, kohlrabi, Brussels sprouts, mustard and charbroiled meats.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Hammersmith Medicines Research: collaborator

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

MeSH Terms

Interventions

Midazolam; olorofim

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• FRANS VANDENBERG

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 12, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

GB (1)