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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:
ClinicalTrials.gov Identifier:
NCT00495729
First Posted: July 3, 2007
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: SB-649868 Drug: Placebo Drug: Simvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • -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 ]

Secondary Outcome Measures:
  • Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14. [ Time Frame: on days -7, 7 and 14. ]

Enrollment: 36
Actual Study Start Date: April 18, 2007
Study Completion Date: August 4, 2007
Primary Completion Date: August 4, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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 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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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 =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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495729


Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00495729     History of Changes
Other Study ID Numbers: OXS104092
First Submitted: June 29, 2007
First Posted: July 3, 2007
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
SB-649868,
Simvastatin
Repeated dose,

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors