Status:
COMPLETED
Food and Relative Bioavailability Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 Healt...
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, singl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00843011
Start Date
August 28 2008
End Date
October 23 2008
Last Update
July 21 2017
Active Locations (1)
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1
GSK Investigational Site
Verona, Veneto, Italy, 37134