A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.

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Detailed Description

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Conditions

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Healthy Subjects Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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GSK626616, placebo, midazolam

Intervention Type DRUG

omeprazole, caffeine, flurbiprofen, rosiglitazone

Intervention Type DRUG

Other Intervention Names

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omeprazole caffeine flurbiprofen rosiglitazone GSK626616 placebo midazolam

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 55 years healthy subjects
* Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
* Females cannot be pregnant.

Exclusion Criteria

* Cannot have exposure to greater than 4 new chemical entities within 12 months.
* Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
* Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
* Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
* Cannot use be taking prescription, non-prescription or illicit drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes