Bioequivalence and Food Effect Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00495274
First received: June 29, 2007
Last updated: May 31, 2012
Last verified: February 2011

June 29, 2007
May 31, 2012
July 2007
September 2007   (final data collection date for primary outcome measure)
  • -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 ]
Same as current
Complete list of historical versions of study NCT00495274 on ClinicalTrials.gov Archive Site
  • -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
  • -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 ]
Not Provided
Not Provided
 
Bioequivalence and Food Effect Study in Healthy Volunteers
See Detailed Description

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
Drug: SB-649868
Other Name: SB-649868
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00495274
OXS105205
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP