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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424462
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):

April 14, 2011
August 29, 2011
June 20, 2017
April 19, 2010
July 6, 2010   (Final data collection date for primary outcome measure)
Systemic concentration & AUC of study drug [ Time Frame: pre-dose, up to 120 hours after each single dose ]
Same as current
Complete list of historical versions of study NCT01424462 on Archive Site
  • Adverse events [ Time Frame: from screening, through study day, and up to follow-up visit. Spontaneous reporting ]
  • Systemic concentration & AUC of study drug metabolite [ Time Frame: pre-dose, up to 120 hours after each single dose ]
  • Vital signs [ Time Frame: screening, pre-dose, up-to 15 hours post does, follow-up visit ]
  • 12-lead Electrocardiogram [ Time Frame: screening, pre-dose and up to 8 hours post dose, then at follow-up ]
  • Heamatology, clinical chemistry and Uninalysis [ Time Frame: screening, predose, up-to 8 hours post dose, follow-up ]
    Blood samples for standard clinical safety monitoring, and unine samples
Same as current
Not Provided
Not Provided
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
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.

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.

Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: A
    Single dose treatment IR formulation
  • Drug: B
    Low Extended release single dose
  • Drug: C
    Medium extended release formulation
  • Drug: D
    High extended release rate single dose
  • Experimental: Firategrast XRA
    Low extended release tablet
    Intervention: Drug: B
  • Experimental: Firategrast XRB
    Medium extended releast tablet
    Intervention: Drug: C
  • Experimental: Firategrast XRC
    High extended release tablet
    Intervention: Drug: D
  • Experimental: Firategrast IR
    Immediate Release reference tablet
    Intervention: Drug: A
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 6, 2010
July 6, 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP