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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: May 31, 2012
Last verified: February 2011
History of Changes
  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
Insomnia
 Drug: SB-649868
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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:

U.S. FDA Resources

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
Study Start Date: April 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-649868
    Other Name: SB-649868
  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 =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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495729

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00495729     History of Changes
Other Study ID Numbers: OXS104092
Study First Received: June 29, 2007
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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 21, 2013