15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

NCT ID: NCT00495729

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-18
• Study Completion Date: 2007-08-04

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.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

Cohort 1

Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.

Group Type: EXPERIMENTAL

SB-649868

Intervention Type: DRUG

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

Simvastatin

Intervention Type: DRUG

Subjects will receive Simvastatin 10 mg tablets orally.

Cohort 2

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.

Group Type: EXPERIMENTAL

SB-649868

Intervention Type: DRUG

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

Simvastatin

Intervention Type: DRUG

Subjects will receive Simvastatin 10 mg tablets orally.

Cohort 3

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.

Group Type: EXPERIMENTAL

SB-649868

Intervention Type: DRUG

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

Simvastatin

Intervention Type: DRUG

Subjects will receive Simvastatin 10 mg tablets orally.

Interventions

SB-649868

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Intervention Type: DRUG

Placebo

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

Intervention Type: DRUG

Simvastatin

Subjects will receive Simvastatin 10 mg tablets orally.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

OXS104092

Identifier Type: -

Identifier Source: org_study_id