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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.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 29, 2007
Last updated: May 31, 2012
Last verified: February 2011
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
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.

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)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00495729

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

Responsible Party: GlaxoSmithKline Identifier: NCT00495729     History of Changes
Other Study ID Numbers: OXS104092
Study First Received: June 29, 2007
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
Repeated dose,

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders processed this record on June 29, 2017