Healthy Volunteer Study Using 3 Different Formulations of Firategrast
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
What it found
We found no results in the registry or in papers.
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Firategrast immediate release tablet
- Firategrast modified release tablet
- Firategrast gastro-retentive solution
What it measured
Main measures
Pharmacokinetic measures for single and repeat dose
Part 1: approx. 4 weeks, Part 2: approx 8 days
How the body handles the medicinePK measures for single and repeat dose
Part 1 approx 4 weeks, Part 2 approx 8 days
How the body handles the medicinePharmacokinetic measurements for single and repeat dose
Part 1: approx 4 weeks, Part 2: approx 8 days
How the body handles the medicine
Other measures (2)
Safety & Tolerability in single and repeat doses
Part 1: approx. 4 weeks, Part 2: approx 8 days
SafetyCD34 positive cell count
Part 1 only approx 4 weeks
Immune response
Who could take part
Relapsing MS · 18 to 65
Show the full 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
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 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.
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History
Started
May 2011
Main results due
Sept 2011
Finished
Sept 2011