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Food and Relative Bioavailability Study (Food/rel BA)

Primary Purpose

Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Orvepitant

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring formulation, safety and tolerability, pharmacokinetics, NK1 antagonist, effect of food

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Orvepitant 60 mg

Outcomes

Primary Outcome Measures

Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2.

Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring

Secondary Outcome Measures

Full Information

NCT ID

NCT00843011

First Posted

February 12, 2009

Last Updated

July 18, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00843011

Brief Title

Food and Relative Bioavailability Study

Acronym

Food/rel BA

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

August 28, 2008 (Actual)

Primary Completion Date

October 23, 2008 (Actual)

Study Completion Date

October 23, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Orvepitant 60 mg

Intervention Type

Drug

Intervention Name(s)

Orvepitant

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2.

Time Frame

72 hours post dose.

Title

Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring

Time Frame

5 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Verona

State/Province

Veneto

ZIP/Postal Code

37134

Country

Italy

12. IPD Sharing Statement

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Food and Relative Bioavailability Study

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