Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies. Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.

Official Title
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An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: A
* Drug: B
* Drug: C
* Drug: D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firategrast XRA<br>Low extended release tablet | Drug: B<br>* Low Extended release single dose<br>|
| Experimental: Firategrast XRB<br>Medium extended releast tablet | Drug: C<br>* Medium extended release formulation<br>|
| Experimental: Firategrast XRC<br>High extended release tablet | Drug: D<br>* High extended release rate single dose<br>|
| Experimental: Firategrast IR<br>Immediate Release reference tablet | Drug: A<br>* Single dose treatment IR formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic concentration & AUC of study drug |  | pre-dose, up to 120 hours after each single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | from screening, through study day, and up to follow-up visit. Spontaneous reporting | 
| Systemic concentration & AUC of study drug metabolite |  | pre-dose, up to 120 hours after each single dose | 
| Vital signs |  | screening, pre-dose, up-to 15 hours post does, follow-up visit | 
| 12-lead Electrocardiogram |  | screening, pre-dose and up to 8 hours post dose, then at follow-up | 
| Heamatology, clinical chemistry and Uninalysis | Blood samples for standard clinical safety monitoring, and unine samples | screening, predose, up-to 8 hours post dose, follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, firategrast, Pharmacokinetics, modified release