Last updated: 11/03/2018 16:14:27
Healthy volunteer pilot study using 3 types of modified release formulations of firategrast to investigate how quickly absorption from the digestive system takes place.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open label, randomised healthy volunteer study to assess the single dose safety and pharmacokinetics of three modified release dosage forms of firategrast
Trial description: 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. The study involves all volunteers receiving all 3 different formulations, as a single dose, and 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 as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Systemic concentration & AUC of study drug
Timeframe: pre-dose, up to 120 hours after each single dose
Secondary outcomes:
Adverse events
Timeframe: from screening, through study day, and up to follow-up visit. Spontaneous reporting
Systemic concentration & AUC of study drug metabolite
Timeframe: pre-dose, up to 120 hours after each single dose
Vital signs
Timeframe: screening, pre-dose, up-to 15 hours post does, follow-up visit
12-lead Electrocardiogram
Timeframe: screening, pre-dose and up to 8 hours post dose, then at follow-up
Heamatology, clinical chemistry and Uninalysis
Timeframe: screening, predose, up-to 8 hours post dose, follow-up
Interventions:
Drug: A
Drug: B
Drug: C
Drug: D
Enrollment:
20
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)
April 2010 to July 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Male or female, 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 or female, aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving informed 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 21 units for males, more than 14 units for females)
- Participation in a clinical trial within 90 days of scheduled first dose
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Will Be 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
2010-06-07
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 114107 can be found on the GSK Clinical Study Register.
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