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Home > Protocol Summaries: Compounds > firategrast > Protocol Summary for 115517

Protocol Summary for 115517

Protocol Summary
Protocol Id: 115517
Secondary Ids:
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
Phase: phase 1
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: No
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 68439
IND/IDE Serial Number:
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
  • Australia: Therapeutic Goods Administration
Collaborators:
  • N/A
Brief Summary: 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.
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.
Record Verification Date: November 2011
Status: Completed
Why Study Stopped:
Study Start Date: May 2011
Study Completion Date: September 2011
Study Completion Date Type: Actual
Primary Completion Date: September 2011
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Pharmacokinetics/dynamics Study
Primary Outcomes:
  • PK measures for single and repeat dose Part 1 approx 4 weeks, Part 2 approx 8 days
  • Pharmacokinetic measures for single and repeat dose Part 1: approx. 4 weeks, Part 2: approx 8 days
  • Pharmacokinetic measurements for single and repeat dose Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary Outcomes:
  • Safety & Tolerability in single and repeat doses Part 1: approx. 4 weeks, Part 2: approx 8 days
  • CD34 positive cell count Part 1 only approx 4 weeks
Conditions:
  • Multiple Sclerosis, Relapsing-Remitting
Keywords:
  • firategrast
  • pharmacokinetics, modified release, firategrast,
  • simulated gastro-retentive
  • pharmacokinetics
  • healthy volunteers, simulated gastro-retentive
  • healthy volunteers
  • modified release
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Male
Minimum Age: 18 Year
Maximum Age: 65 Year
Enrollment: 38
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GlaxoSmithKline
Location and Contact Information: Click to view location information