Healthy Volunteer Study Using 3 Different Formulations of Firategrast

NCT ID: NCT01416363

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-20
• Study Completion Date: 2011-09-17

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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.

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

Treatment Arm D: Part 2

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

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

Treatment Arm E: Part 2

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

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

Treatment Arm F: Part 2

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

Group Type: EXPERIMENTAL

Firategrast immediate release tablet

Intervention Type: DRUG

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.

Firategrast modified release tablet

Intervention Type: DRUG

Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.

Firategrast gastro-retentive solution

Intervention Type: DRUG

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Firategrast gastro-retentive solution

Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

115517

Identifier Type: -

Identifier Source: org_study_id