Status:
COMPLETED
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Anaemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00443170
Start Date
November 1 2006
Last Update
March 19 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
2
GSK Investigational Site
Herston, Queensland, Australia, 4006
3
GSK Investigational Site
Adelaide, South Australia, Australia, 5000