A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
45
F901318 tablet
Covance Clinical Research Unit
Leeds, West Yorkshire, United Kingdom
Incidence of treatment emergent adverse events
safety and tolerability
Time frame: 18 days
Area under the curve (AUC) 0-tau for F901318
Pharmacokinetics (PK) of oral doses of F90318
Time frame: 11 days
maximum plasma concentration (Cmax) for F901318
PK of oral doses of F90318
Time frame: 11 days
minimum plasma concentration (Cmin) for F901318
PK of oral doses of F90318
Time frame: 11 days
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