Food and Relative Bioavailability Study (Food/rel BA)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00843011
First received: February 12, 2009
Last updated: May 29, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: Orvepitant
Phase 1

Study Type: Interventional
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Orvepitant 60 mg
Drug: Orvepitant
Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female between 18 and 65 years of age inclusive.
  • A female subject is eligible to participate if she is of either non-childbearing potential or child-bearing potential and agrees to use one of the contraception methods
  • No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview (M.I.N.I) scale.
  • A 12-lead ECG at screening showed no abnormalities that in the opinion of the Principal Investigator will compromise safety in this study.

    -- Body weight ≥ 50 kg and BMI within the range 19.0 - 29.9 kg/m2 (inclusive).

  • Capable of giving written informed consent

Exclusion Criteria:

  • As a result of any of the medical interview, physical examination or screening investigations the Physician Responsible considers the subject unfit for the study.
  • The subject has a history of a drug or other allergy which in the opinion of the Physician Responsible contraindicates the participation in the study.
  • Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of orvepitant, may pose a safety concern, or interfere with accurate assessment of safety.
  • The subject has a current or recent (within six months) documented gastrointestinal disease; a history of malabsorption, oesophageal reflux, or irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn, or any surgical intervention (e.g. cholecystectomy) which would be expected to influence the absorption of drugs.
  • History of psychiatric illness
  • Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
  • Subject is consuming alcool or tobacco
  • Subject is positive to Hepatitis B, C or HIV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843011

Locations
Italy
GSK Investigational Site
Verona, Veneto, Italy, 37134
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00843011     History of Changes
Other Study ID Numbers: 110355
Study First Received: February 12, 2009
Last Updated: May 29, 2009
Health Authority: Italy: Comitato Etico Azienda Ospedaliera di Verona
Italy: Isituto Superiore di Sanita'
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
NK1 antagonist
effect of food
safety and tolerability
pharmacokinetics
formulation

ClinicalTrials.gov processed this record on April 23, 2014