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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: A
Drug: B
Drug: C
Drug: D
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Systemic concentration & AUC of study drug [ Time Frame: pre-dose, up to 120 hours after each single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Firategrast XRA
Low extended release tablet
 Drug: B
Low Extended release single dose
Experimental: Firategrast XRB
Medium extended releast tablet
 Drug: C
Medium extended release formulation
Experimental: Firategrast XRC
High extended release tablet
 Drug: D
High extended release rate single dose
Experimental: Firategrast IR
Immediate Release reference tablet
 Drug: A
Single dose treatment IR formulation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424462

Locations
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424462     History of Changes
Other Study ID Numbers: 114107
Study First Received: April 14, 2011
Last Updated: March 8, 2012
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
healthy volunteers
firategrast
Pharmacokinetics
modified release

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013