Status:
COMPLETED
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will investigate how 3 new 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...
Detailed Description
The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified rel...
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving informed 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 21 units for males, more than 14 units for females)
- Participation in a clinical trial within 90 days of scheduled first dose
Key Trial Info
Start Date :
April 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01424462
Start Date
April 19 2010
End Date
July 6 2010
Last Update
June 20 2017
Active Locations (1)
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1
GSK Investigational Site
Randwick, New South Wales, Australia, 2031