Food and Relative Bioavailability Study (Food/rel BA)
This study is an open-label, randomised, single dose study to determine the pharmacokinetics, safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of food in 15 Healthy Volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Open-Label, Randomized, Single-Dose, 3-Way Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of 2 Different Formulations of Orvepitant and the Effect of Food in Healthy Volunteers.|
- Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2. [ Time Frame: 72 hours post dose. ] [ Designated as safety issue: No ]
- Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring [ Time Frame: 5 weeks. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Orvepitant 60 mg
Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.
Orvepitant is a highly potent and selective neurokinin-1 (NK1) receptor antagonist currently in development for the treatment of depression and anxiety.
This study is an open-label, randomised, single dose study to determine the pharmacokinetics, safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of food in 15 Healthy Volunteers. According to a cross over design, in three different occasions, each subject will receive the "old" formulation of orvepitant in fasted condition and the "new" formulation in fasted condition and after a FDA High-Fat Breakfast. Subjects will be screened within 21 days of first treatment. On each dosing occasion, subjects will be admitted to the clinic on Day-1 and will remain until Day 2; they will be also asked to return to the site 48 and 72 hours after each dosing for the PK blood sample collection. The wash-out period between each dosing occasion will be at least 5 days and subjects will be asked to return to the site 7-14 days after the administration of the last dose of orvepitant for a follow-up visit.