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15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00495729
First received: June 29, 2007
Last updated: August 5, 2017
Last verified: August 2017
June 29, 2007
August 5, 2017
April 18, 2007
August 4, 2007   (Final data collection date for primary outcome measure)
  • -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days) [ Time Frame: after the SD and 14 days RD period (15 days) ]
  • - SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose) [ Time Frame: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose) ]
  • - Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15 [ Time Frame: on days -10,1,4,7 and 15 ]
Same as current
Complete list of historical versions of study NCT00495729 on ClinicalTrials.gov Archive Site
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14. [ Time Frame: on days -7, 7 and 14. ]
Same as current
Not Provided
Not Provided
 
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.
Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: SB-649868
    Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
  • Drug: Placebo
    Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
  • Drug: Simvastatin
    Subjects will receive Simvastatin 10 mg tablets orally.
  • Experimental: Cohort 1
    Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.
    Interventions:
    • Drug: SB-649868
    • Drug: Placebo
    • Drug: Simvastatin
  • Experimental: Cohort 2
    Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin.
    Interventions:
    • Drug: SB-649868
    • Drug: Placebo
    • Drug: Simvastatin
  • Experimental: Cohort 3
    Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin.
    Interventions:
    • Drug: SB-649868
    • Drug: Placebo
    • Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 4, 2007
August 4, 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 =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
  • Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
  • Subjects will have blood pressure measurements within the normal range for healthy volunteers.

Exclusion Criteria:

  • The subject has a positive pre-study urine drug/ alcohol urine screen.
  • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
  • Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
  • Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00495729
OXS104092
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

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