Protocol Summary for 110355

Protocol Summary
Protocol Id: 110355
Secondary Ids:
  • N/A
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?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 101142
IND/IDE Serial Number: 101142
Has Expanded Access?: No
Study Type: interventional
Oversight Authority:
  • Italy: Comitato Etico Azienda Ospedaliera di Verona
  • Italy: Isituto Superiore di Sanita'
  • United States: Food and Drug Administration
Collaborators:
  • N/A
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
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Bio-availability Study
Primary Outcomes:
  • Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2. no 72 hours post dose.
  • Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring yes 5 weeks.
Secondary Outcomes:
  • Not Applicable
Conditions:
  • Healthy volunteer
Keywords:
  • NK1 antagonist
  • effect of food
  • safety and tolerability
  • pharmacokinetics
  • formulation
Eligibility Criteria: Click to view inclusion/exclusion 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