Last updated: 11/03/2018 18:12:53
Healthy volunteer study using 3 different formulations of Firategrast
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single/repeat dose study with three oral formulations of Firategrast (immediate release tablet, modified release tablet, and naso-gastric infusion) in healthy male volunteers
Trial description: 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. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetic measures for single and repeat dose
Timeframe: Part 1: approx. 4 weeks, Part 2: approx 8 days
PK measures for single and repeat dose
Timeframe: Part 1 approx 4 weeks, Part 2 approx 8 days
Pharmacokinetic measurements for single and repeat dose
Timeframe: Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary outcomes:
Safety & Tolerability in single and repeat doses
Timeframe: Part 1: approx. 4 weeks, Part 2: approx 8 days
CD34 positive cell count
Timeframe: Part 1 only approx 4 weeks
Interventions:
Drug: Firategrast immediate release tablet
Drug: Firategrast modified release tablet
Drug: Firategrast gastro-retentive solution
Enrollment:
38
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis, Relapsing-Remitting
Product
firategrast
Collaborators
Not applicable
Study date(s)
May 2011 to September 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Positive drugs of abuse result
- Positive for HIV or Hepatitis B and/or C viruses
Inclusion and exclusion criteria
Inclusion criteria:
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving iformed consent
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-17-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 115517 can be found on the GSK Clinical Study Register.
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