This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.
The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Single oral dose
Algorithme Pharma Inc
Québec, Canada
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
Time frame: up to 24 hours post-dose.
Number of Participants Who Were Evaluated for Adverse Events
Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0
Time frame: 7 days
Pharmacokinetic Parameters
Peak Plasma Concentration (Cmax)
Time frame: up to 24 hours post-dose.
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