Last updated: 11/04/2018 10:08:48

Bioequivalence and Food Effect Study in Healthy Volunteers

GSK study ID
OXS105205
See study documents
Clinicaltrials.gov ID
NCT00495274
EudraCT ID
2006-002129-22
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

-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

Timeframe: 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

Timeframe: predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose

Secondary outcomes:

-AE, Lab values and cardiovascular monitoring throughout study participation

Timeframe: throughout study participation

-Romberg heel-to-toe test at discharge

Timeframe: at discharge

-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose

Timeframe: predose, 0.5, 1, 2, 4, 6 hours post-dose

Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score

Timeframe: pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1

Interventions:
  • Drug: Formulation A
  • Drug: Formulation B
  • Drug: Formulation C
  • Drug: Formulation D
  • Drug: Formulation E
  • Drug: Formulation F
  • Drug: Formulation G
    • Enrollment:
    16
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Initiation and Maintenance Disorders
    Product
    SB649868
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to September 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy adult male subjects aged between 18 and 65 years of age inclusive.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Verona, Veneto, Italy, 37134
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-26-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study OXS105205 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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