Last updated: 11/03/2018 10:59:38
Food and relative bioavailability studyFood/rel BA
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: This study is an open-label, randomised, single dose study to determine thepharmacokinetics, safety and tolerability of 2 different formulations of orvepitant 60 mgand the effect of food in 15 Healthy Volunteers.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2.
Timeframe: 72 hours post dose.
Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring
Timeframe: 5 weeks.
Secondary outcomes:
Not applicable
Interventions:
Drug: Orvepitant
Enrollment:
14
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
orvepitant
Collaborators
Not applicable
Study date(s)
August 2008 to October 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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
- As a result of any of the medical interview, physical examination or screening
- investigations the Physician Responsible considers the subject unfit for the study.
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-23-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 110355 can be found on the GSK Clinical Study Register.
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