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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: July 5, 2017
Last verified: July 2017
  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: Firategrast immediate release tablet Drug: Firategrast modified release tablet Drug: Firategrast gastro-retentive solution Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 ]
    Cmax of firategrast

  • PK measures for single and repeat dose [ Time Frame: Part 1 approx 4 weeks, Part 2 approx 8 days ]
    AUC(0-t) of firategrast

  • Pharmacokinetic measurements for single and repeat dose [ Time Frame: Part 1: approx 4 weeks, Part 2: approx 8 days ]
    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 ]
    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 ]
    as data permit - exploratory measure


Enrollment: 38
Actual Study Start Date: May 20, 2011
Study Completion Date: September 17, 2011
Primary Completion Date: September 17, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm ACB: Part 1
Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm BAC: Part 1
Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm CBA: Part 1
Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm BCA: Part 1
Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm CAB: Part 1
Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm ABC: Part 1
Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm D: Part 2
Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm E: Part 2
Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Experimental: Treatment Arm F: Part 2
Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days
Drug: Firategrast immediate release tablet
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Drug: Firategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Drug: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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   (Adult)
Sexes 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416363     History of Changes
Other Study ID Numbers: 115517
Study First Received: June 23, 2011
Last Updated: July 5, 2017

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
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 17, 2017