Status:
COMPLETED
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study will investigate how 3 types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. Th...
Detailed Description
The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing i...
Eligibility Criteria
Inclusion
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving iformed consent
Exclusion
- Positive drugs of abuse result
- Positive for HIV or Hepatitis B and/or C viruses
- History of alcohol consumption in excess of average recommended weekly intake (more than 12 units for males)
- Participation in a clinical trial within 30 days of scheduled first dose
Key Trial Info
Start Date :
May 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01416363
Start Date
May 20 2011
End Date
September 17 2011
Last Update
July 7 2017
Active Locations (1)
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1
GSK Investigational Site
Randwick, New South Wales, Australia, 2031