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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
History of Changes
  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
Sleep Initiation and Maintenance Disorders
Insomnia
 Drug: SB-649868
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Insomnia
U.S. FDA Resources

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)
Intervention Details:
    Drug: SB-649868
    Other Name: SB-649868
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
GSK Investigational Site
Verona, Veneto, Italy, 37134
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00495274     History of Changes
Other Study ID Numbers: OXS105205
Study First Received: June 29, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Bioequivalent
pharmacodynamic
Reference formulation
 5 new formulation
Food effect
Pharmacokinetics

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013