Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formul
An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- A
- B
- C
- D
What it measured
Main measures
Systemic concentration & AUC of study drug
pre-dose, up to 120 hours after each single dose
How the body handles the medicine
Other measures (5)
Adverse events
from screening, through study day, and up to follow-up visit. Spontaneous reporting
SafetySystemic concentration & AUC of study drug metabolite
pre-dose, up to 120 hours after each single dose
How the body handles the medicineVital signs
screening, pre-dose, up-to 15 hours post does, follow-up visit
Safety12-lead Electrocardiogram
screening, pre-dose and up to 8 hours post dose, then at follow-up
Heamatology, clinical chemistry and Uninalysis
screening, predose, up-to 8 hours post dose, follow-up
Safety
Who could take part
Relapsing MS · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Apr 2010
Main results due
Jul 2010
Finished
Jul 2010