Last updated: 11/04/2018 10:08:34
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
-AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)
Timeframe: 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)
Timeframe: 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
Timeframe: on days -10,1,4,7 and 15
Secondary outcomes:
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
Timeframe: on days -7, 7 and 14.
Interventions:
Drug: SB-649868
Drug: Placebo
Drug: Simvastatin
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep Initiation and Maintenance Disorders
Product
SB649868
Collaborators
Not applicable
Study date(s)
April 2007 to August 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-04-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study OXS104092 can be found on the GSK Clinical Study Register.
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