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A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.

NCT01299597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-07-21

No results posted yet for this study

Summary

The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.

Conditions

  • Sleep Disorders

Interventions

DRUG

Atorvastatin

20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.

DRUG

Simvastatin

10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.

DRUG

SB649868

20mg daily given for 14 days.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-18
Primary Completion
2010-02-26
Completion
2010-02-26

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 NCT01299597 on ClinicalTrials.gov