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

Phase 1

Completed

• Conditions: Healthy Subjects; Anaemia

• Registration Number: NCT00443170
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-05
• Status Verified: 2011-02
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
adverse events at end of each cohort	end of each cohort
hematology/chemistry/urinalysis at end of each cohort	end of each cohort
physical examination at end of each cohort	end of each cohort
vital signs and electrocardiogram (ECG) at end of each cohort	end of each cohort

Secondary Outcome Measures

Name	Time	Method
GSK626616 pharmacokinetics at end of each cohort	end of each cohort
hemoglobin at end of each cohort	end of each cohort
red blood cell measurements at end of each cohort	end of each cohort
estimates of CYP enzyme activity at end of study	end of study
mRNA levels in peripheral blood at end of study	end of study

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Adelaide, South Australia, Australia