Healthy Volunteer Study Using 3 Different Formulations of Firategrast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01416363
First received: June 23, 2011
Last updated: March 8, 2012
Last verified: November 2011
  Purpose

This study will investigate how 3 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 is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. 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 a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: A
Drug: B
Drug: C
Drug: D
Drug: E
Drug: F
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: A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic measures for single and repeat dose [ Time Frame: Part 1: approx. 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]
    Cmax of firategrast

  • PK measures for single and repeat dose [ Time Frame: Part 1 approx 4 weeks, Part 2 approx 8 days ] [ Designated as safety issue: No ]
    AUC(0-t) of firategrast

  • Pharmacokinetic measurements for single and repeat dose [ Time Frame: Part 1: approx 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]
    AUC(0-24) of firategrast


Secondary Outcome Measures:
  • Safety & Tolerability in single and repeat doses [ Time Frame: Part 1: approx. 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]
    Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis

  • CD34 positive cell count [ Time Frame: Part 1 only approx 4 weeks ] [ Designated as safety issue: No ]
    as data permit - exploratory measure


Enrollment: 38
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Firategrast immediate release tablet Drug: A
Single dose Firategrast immediate release formulation
Drug: D
Repeat dose Firategrast immediate release formulation
Experimental: Firategrast modified release tablet Drug: B
Single dose Firategrast modified release formulation
Drug: E
Repeat dose Firategrast modified release formulation
Experimental: Firategrast gastro-retentive solution Drug: C
Single dose Firategrast simulated gastro-retentive formulation
Drug: F
Repeat dose Firategrast simulated gastro-retentive formulation

Detailed Description:

The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose crossover fashion.

Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.

  Eligibility

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

Inclusion Criteria:

  • Male aged 18 to 65 yrs inclusive
  • Healthy, as determined by study physician
  • Capable of giving iformed 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 12 units for males)
  • Participation in a clinical trial within 30 days of scheduled first dose
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416363

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: NCT01416363     History of Changes
Other Study ID Numbers: 115517
Study First Received: June 23, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
firategrast
pharmacokinetics, modified release, firategrast,
simulated gastro-retentive
pharmacokinetics
healthy volunteers, simulated gastro-retentive
healthy volunteers
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

ClinicalTrials.gov processed this record on September 18, 2014