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
Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate
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.
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 →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.
Exclusion Criteria:
Pharmacokinetic profile of midazolam 2 mg orally when given after dosing with F901318 to steady state.
Drug: Midazolam with F901318
Pharmacokinetics of midazolam with F901318
area under concentration/time curve
AUC0-24
Time frame: 24 hours
safety and tolerability as assessed by number of treatment related adverse events
adverse events
Time frame: 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
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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F2G Biotech GmbH