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Healthy Volunteer Study Using 3 Different Formulations of Firategrast

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Firategrast immediate release tablet
Firategrast modified release tablet
Firategrast gastro-retentive solution
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring firategrast, pharmacokinetics, modified release, firategrast,, simulated gastro-retentive, pharmacokinetics, healthy volunteers, simulated gastro-retentive, healthy volunteers, modified release

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Arm ACB: Part 1

Treatment Arm BAC: Part 1

Treatment Arm CBA: Part 1

Treatment Arm BCA: Part 1

Treatment Arm CAB: Part 1

Treatment Arm ABC: Part 1

Treatment Arm D: Part 2

Treatment Arm E: Part 2

Treatment Arm F: Part 2

Arm Description

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.

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.

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.

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.

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.

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.

Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days

Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days

Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days

Outcomes

Primary Outcome Measures

Pharmacokinetic measures for single and repeat dose
Cmax of firategrast
PK measures for single and repeat dose
AUC(0-t) of firategrast
Pharmacokinetic measurements for single and repeat dose
AUC(0-24) of firategrast

Secondary Outcome Measures

Safety & Tolerability in single and repeat doses
Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis
CD34 positive cell count
as data permit - exploratory measure

Full Information

First Posted
June 23, 2011
Last Updated
July 5, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01416363
Brief Title
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 20, 2011 (Actual)
Primary Completion Date
September 17, 2011 (Actual)
Study Completion Date
September 17, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
firategrast, pharmacokinetics, modified release, firategrast,, simulated gastro-retentive, pharmacokinetics, healthy volunteers, simulated gastro-retentive, healthy volunteers, modified release

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm ACB: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm BAC: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm CBA: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm BCA: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm CAB: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm ABC: Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm D: Part 2
Arm Type
Experimental
Arm Description
Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days
Arm Title
Treatment Arm E: Part 2
Arm Type
Experimental
Arm Description
Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days
Arm Title
Treatment Arm F: Part 2
Arm Type
Experimental
Arm Description
Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Firategrast immediate release tablet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Firategrast modified release tablet
Intervention Description
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Intervention Type
Drug
Intervention Name(s)
Firategrast gastro-retentive solution
Intervention Description
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Primary Outcome Measure Information:
Title
Pharmacokinetic measures for single and repeat dose
Description
Cmax of firategrast
Time Frame
Part 1: approx. 4 weeks, Part 2: approx 8 days
Title
PK measures for single and repeat dose
Description
AUC(0-t) of firategrast
Time Frame
Part 1 approx 4 weeks, Part 2 approx 8 days
Title
Pharmacokinetic measurements for single and repeat dose
Description
AUC(0-24) of firategrast
Time Frame
Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary Outcome Measure Information:
Title
Safety & Tolerability in single and repeat doses
Description
Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis
Time Frame
Part 1: approx. 4 weeks, Part 2: approx 8 days
Title
CD34 positive cell count
Description
as data permit - exploratory measure
Time Frame
Part 1 only approx 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Healthy Volunteer Study Using 3 Different Formulations of Firategrast

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