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CompletedNCT02680808Updated Jun 9, 2016

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

A Phase 1 interventional study of Midazolam with F901318 in Invasive Aspergillosis, sponsored by F2G Biotech GmbH. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-09.

Sponsored by F2G Biotech GmbH · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the detailed description

This will be an open label study of midazolam (dose 2 mg orally, Day 1) followed by midazolam (2 mg orally) given after dosing with intravenous F901318 4 mg/kg bid for one day followed by 2.5 mg/kg bid for 7 doses (Day 7). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of midazolam and F901318 and undergo the same procedures. The first cohort will consist of 12 subjects studied in two groups of six subjects each. If there is clearly a difference in midazolam kinetics detectable between the first and second doses of midazolam, in this first cohort, the second cohort will not be studied. If there is no clear difference, the second cohort will also be studied to give a final result. PK sampling for midazolam and 1- and 4-hydroxymidazolam plasma and urine concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions. PK sampling for F901318 will continue from before the first dose and up to 24 hours after the ninth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the clinical unit following completion of blood sampling following the second dose of midazolam and the ninth dose of F901318.

02

Conditions studied

  • Invasive Aspergillosis

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03

In context

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 106 interventional studies indexed under Aspergillosis.

Browse Aspergillosis studies →

Lead sponsor

F2G Biotech GmbH is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive.
  2. 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).
  3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
  4. Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.

Exclusion criteria

Exclusion Criteria:

  1. Male subjects who are not willing to use appropriate contraception during the study and for three months thereafter.
  2. 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.
  3. 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.
  4. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    midazolam with F901318

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

    Drug: Midazolam with F901318

Interventions

  • DrugMidazolam with F901318

    Pharmacokinetics of midazolam with F901318

06

What researchers measure

Primary outcomes

  1. area under concentration/time curve

    AUC0-24

    Time frame: 24 hours

Secondary outcomes

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

    adverse events

    Time frame: 24 hours

07

Study locations

1 site
  • Hammersmith Medicines Research
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02680808
Lead sponsor
F2G Biotech GmbH
Collaborators
Hammersmith Medicines Research
Responsible party
Sponsor
First posted
Feb 12, 2016
Start date
Jan 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 9, 2016

Study contacts

FRANS VANDENBERG
principal investigator · Hammersmith Medicines Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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