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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:
ClinicalTrials.gov Identifier:
NCT01424462
First Posted: August 29, 2011
Last Update Posted: June 20, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Actual Study Start Date: April 19, 2010
Study Completion Date: July 6, 2010
Primary Completion Date: July 6, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424462     History of Changes
Other Study ID Numbers: 114107
First Submitted: April 14, 2011
First Posted: August 29, 2011
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
healthy volunteers
firategrast
Pharmacokinetics
modified release

Additional relevant MeSH terms:
Multiple 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