Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

April 21, 2007

Primary Completion Date

November 26, 2007

Study Completion Date

November 26, 2007

Conditions
Multiple Sclerosis
Interventions
DRUG

Formulation A

Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.

DRUG

Formulation B

Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.

DRUG

Formulation C

Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.

DRUG

Formulation D

Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.

Trial Locations (4)

10117

GSK Investigational Site, Berlin

150 18

GSK Investigational Site, Prague

05-825

GSK Investigational Site, Grodzisk Mazowiecki

60-479

GSK Investigational Site, Poznan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY