Food and Relative Bioavailability Study

NCT00843011 | Completed Phase 1

• 1 other identifier: 110355
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

formulation; safety and tolerability; pharmacokinetics; NK1 antagonist; effect of food

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

Orvepitant 60 mg

Drug: Orvepitant

Interventions

Orvepitant DRUG

Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Verona, Veneto, 37134, Italy

Location

Related Links

• Results for study 110355 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Depressive Disorder

Interventions

orvepitant

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: August 28, 2008
• Primary Completion: October 23, 2008
• Study Completion: October 23, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

IT (1)