Food and Relative Bioavailability Study (Food/rel BA)
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|ClinicalTrials.gov Identifier: NCT00843011|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Drug: Orvepitant||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||August 28, 2008|
|Actual Primary Completion Date :||October 23, 2008|
|Actual Study Completion Date :||October 23, 2008|
Experimental: Arm 1
Orvepitant 60 mg
Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.
- Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2. [ Time Frame: 72 hours post dose. ]
- Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring [ Time Frame: 5 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843011
|GSK Investigational Site|
|Verona, Veneto, Italy, 37134|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|