Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title: An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis

Status Completed

Clinical Trial Summary

Sufficient subjects with a confirmed diagnosis of MS (EDSS score of 6.5 or below), will be recruited to ensure that 30 subjects (approx. equal numbers of each gender) complete the study. Subjects will undergo a screening visit, then four study days, each separated by a washout period of at least 7 days, when the different firategrast batches of drug substance will be administered, and a follow-up visit.

Clinical Trial Description

An open-label, randomised, four period crossover study to investigate the relative pharmacokinetic profiles of tablets from three batches of firategrast with different surface areas and two different tablet formulations containing the same batch of firategrast, given as single 900mg doses to male and female subjects with a diagnosis of Multiple Sclerosis ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00548769
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2007
• Completion date: November 26, 2007