| Protocol Id: | 110355 |
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| 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. |
| Phase: | Phase 1 |
| Acronym: | Food/rel BA |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
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| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CDER |
| IND/IDE Number: | 101142 |
| IND/IDE Serial Number: | 101142 |
| Has Expanded Access?: | No |
| Study Type: | interventional |
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| Brief Summary: | 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. |
| Detailed Description: | 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. |
| Record Verification Date: | September 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | August 2008 |
| Study Completion Date: | November 2008 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | October 2008 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | Treatment |
| Allocation: | Randomized |
| Masking: | Open Label |
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| Study Design (Assignment): | Crossover Assignment |
| Study Classification (Endpoint): | Bio-availability Study |
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| Eligibility Criteria: | Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 years |
| Maximum Age: | 65 years |
| Enrollment: | 14 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | Yes |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | info@clinicaltrialsforgsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | 0800 007 5189 |
| Backup Central Contact Email: | info@clinicaltrialsforgsk.com |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Study Director |
| Responsible Party Organization: | GSK |
| Location and Contact Information: |
Click to view location information
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