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

NCT00495729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-08

No results posted yet for this study

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

Interventions

DRUG

SB-649868

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

DRUG

Placebo

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

DRUG

Simvastatin

Subjects will receive Simvastatin 10 mg tablets orally.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-18
Primary Completion
2007-08-04
Completion
2007-08-04

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495729 on ClinicalTrials.gov