Sleep Initiation and Maintenance Disorders
Conditions
Keywords
SB-649868,, Simvastatin, Repeated dose,
Brief summary
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.
Interventions
DRUGSB-649868
Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
DRUGPlacebo
Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
DRUGSimvastatin
Subjects will receive Simvastatin 10 mg tablets orally.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days) | 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) | 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 | on days -10,1,4,7 and 15 |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14. | on days -7, 7 and 14. |
Countries
Germany
Outcome results
None listed