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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424462
First received: April 14, 2011
Last updated: March 8, 2012
Last verified: August 2011

April 14, 2011
March 8, 2012
April 2010
June 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01424462 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: from screening, through study day, and up to follow-up visit. Spontaneous reporting ] [ Designated as safety issue: Yes ]
  • Systemic concentration & AUC of study drug metabolite [ Time Frame: pre-dose, up to 120 hours after each single dose ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: screening, pre-dose, up-to 15 hours post does, follow-up visit ] [ Designated as safety issue: Yes ]
  • 12-lead Electrocardiogram [ Time Frame: screening, pre-dose and up to 8 hours post dose, then at follow-up ] [ Designated as safety issue: Yes ]
  • Heamatology, clinical chemistry and Uninalysis [ Time Frame: screening, predose, up-to 8 hours post dose, follow-up ] [ Designated as safety issue: Yes ]
    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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2010
June 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01424462
114107
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2011

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