Healthy Volunteer Study Using 3 Different Formulations of Firategrast

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416363

115517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 9 patient groups

Treatment Arm ACB: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm BAC: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm CBA: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm BCA: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm CAB: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm ABC: Part 1

Experimental group

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.

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm D: Part 2

Experimental group

Description:

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

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm E: Part 2

Experimental group

Description:

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

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet

Treatment Arm F: Part 2

Experimental group

Description:

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

Treatment:

Drug: Firategrast immediate release tablet

Drug: Firategrast gastro-retentive solution

Drug: Firategrast modified release tablet