Back to results15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
SB-649868
Placebo
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring SB-649868,, Simvastatin, Repeated dose,
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.
Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin.
Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin.
Outcomes
Primary Outcome Measures
-AE, Lab values and cardiovascular monitoring 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)
- Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15
Secondary Outcome Measures
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495729
Brief Title
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 18, 2007 (Actual)
Primary Completion Date
August 4, 2007 (Actual)
Study Completion Date
August 4, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
SB-649868,, Simvastatin, Repeated dose,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin.
Intervention Type
Drug
Intervention Name(s)
SB-649868
Intervention Description
Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Subjects will receive Simvastatin 10 mg tablets orally.
Primary Outcome Measure Information:
Title
-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)
Title
- 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)
Title
- 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 Measure Information:
Title
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
Time Frame
on days -7, 7 and 14.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
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15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
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