Food and Relative Bioavailability Study
- Registration Number
- NCT00843011
- Lead Sponsor
- GlaxoSmithKline
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 Orvepitant Orvepitant 60 mg
- Primary Outcome Measures
Name Time Method Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2. 72 hours post dose. Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring 5 weeks.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇮🇹Verona, Veneto, Italy