Healthy Volunteer Study Using 3 Different Formulations of Firategrast

NCT01416363 | Completed Phase 1

• 1 other identifier: 115517
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

firategrast; pharmacokinetics, modified release, firategrast,; simulated gastro-retentive; pharmacokinetics; healthy volunteers, simulated gastro-retentive; healthy volunteers; modified release

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic measures for single and repeat dose

  Cmax of firategrast

  Part 1: approx. 4 weeks, Part 2: approx 8 days

• PK measures for single and repeat dose

  AUC(0-t) of firategrast

  Part 1 approx 4 weeks, Part 2 approx 8 days

• Pharmacokinetic measurements for single and repeat dose

  AUC(0-24) of firategrast

  Part 1: approx 4 weeks, Part 2: approx 8 days

Secondary Outcomes (2)

• 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

Study Arms (9)

Treatment Arm ACB: Part 1

EXPERIMENTAL

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

Treatment Arm BAC: Part 1

EXPERIMENTAL

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

Treatment Arm CBA: Part 1

EXPERIMENTAL

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

Treatment Arm BCA: Part 1

EXPERIMENTAL

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

Treatment Arm CAB: Part 1

EXPERIMENTAL

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

Treatment Arm ABC: Part 1

EXPERIMENTAL

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

Treatment Arm D: Part 2

EXPERIMENTAL

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

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

Treatment Arm E: Part 2

EXPERIMENTAL

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

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

Treatment Arm F: Part 2

EXPERIMENTAL

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

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

Interventions

Firategrast immediate release tablet 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.

Treatment Arm ABC: Part 1; Treatment Arm ACB: Part 1; Treatment Arm BAC: Part 1; Treatment Arm BCA: Part 1; Treatment Arm CAB: Part 1; Treatment Arm CBA: Part 1; Treatment Arm D: Part 2; Treatment Arm E: Part 2; Treatment Arm F: Part 2

Firategrast modified release tablet DRUG

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

Treatment Arm ABC: Part 1; Treatment Arm ACB: Part 1; Treatment Arm BAC: Part 1; Treatment Arm BCA: Part 1; Treatment Arm CAB: Part 1; Treatment Arm CBA: Part 1; Treatment Arm D: Part 2; Treatment Arm E: Part 2; Treatment Arm F: Part 2

Firategrast gastro-retentive solution DRUG

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

Treatment Arm ABC: Part 1; Treatment Arm ACB: Part 1; Treatment Arm BAC: Part 1; Treatment Arm BCA: Part 1; Treatment Arm CAB: Part 1; Treatment Arm CBA: Part 1; Treatment Arm D: Part 2; Treatment Arm E: Part 2; Treatment Arm F: Part 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged 18 to 65 yrs inclusive
• Healthy, as determined by study physician
• Capable of giving iformed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Links

• Results for study 115517 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Firategrast

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: August 15, 2011
• Study Start: May 20, 2011
• Primary Completion: September 17, 2011
• Study Completion: September 17, 2011
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

AU (1)