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):
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.
Sleep Initiation and Maintenance Disorders
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
||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.
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. ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2007 (Final data collection date for primary outcome measure)
Other Name: SB-649868
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00495729
|GSK Investigational Site
|Berlin, Germany, 14050 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 29, 2007
||May 31, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on September 18, 2014