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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-19

Study Completion Date

2010-07-06

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.

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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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Firategrast XRA

Low extended release tablet

Group Type EXPERIMENTAL

B

Intervention Type DRUG

Low Extended release single dose

Firategrast XRB

Medium extended releast tablet

Group Type EXPERIMENTAL

C

Intervention Type DRUG

Medium extended release formulation

Firategrast XRC

High extended release tablet

Group Type EXPERIMENTAL

D

Intervention Type DRUG

High extended release rate single dose

Firategrast IR

Immediate Release reference tablet

Group Type EXPERIMENTAL

A

Intervention Type DRUG

Single dose treatment IR formulation

Interventions

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A

Single dose treatment IR formulation

Intervention Type DRUG

B

Low Extended release single dose

Intervention Type DRUG

C

Medium extended release formulation

Intervention Type DRUG

D

High extended release rate single dose

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes