Bioequivalence and Food Effect Study in Healthy Volunteers - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00495274

Purpose

The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

Condition	Intervention	Phase
Insomnia	Drug: SB-649868	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

-Part A: SB-649868 levels of 6 formulation predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose [ Time Frame: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose ]
-Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A [ Time Frame: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose ]

Secondary Outcome Measures:

-AE, Lab values and cardiovascular monitoring throughout study participation [ Time Frame: throughout study participation ]
-Romberg heel-to-toe test at discharge [ Time Frame: at discharge ]
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose [ Time Frame: predose, 0.5, 1, 2, 4, 6 hours post-dose ]
Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score

Enrollment:	16
Study Start Date:	July 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic (Part B) in healthy male volunteers

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy adult male subjects aged between 18 and 65 years of age inclusive.
Body weight and BMI within the protocol ranges.
Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
Circulating levels of LH, FSH and testosterone within the normal reference range.
Signed and dated written informed consent.
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria:

Positive pre-study urine drug screen and alcohol breath test.
Positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV ½ result.
Abuse of alcohol as per protocol criteria.
Consumption of prohibited food and drink as per protocol.
Subject who is not prepared to eat the standard meals provided by the site.
Use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication.
Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.
History or presence of allergy to the study drug or drugs of this class, or a history of other allergy.
Smoking history in the last three months as per protocol.
An unwillingness of male subjects to follow contraception methods as per protocol.
History or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period.
Current or previous (within 6 months) participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495274

Locations

Italy, Veneto
GSK Investigational Site
Verona, Veneto, Italy, 37134

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OXS105205
Study First Received:	June 29, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00495274 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Bioequivalent
Food effect
Reference formulation

5 new formulation
Pharmacokinetics
pharmacodynamic

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on July 02, 2009