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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014