Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.

NCT01424462 | Completed Phase 1

• 1 other identifier: 114107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate how 3 new 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 involves all volunteers receiving all 3 different formulations, as a single dose, and 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 as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

healthy volunteers; firategrast; Pharmacokinetics; modified release

Outcome Measures

Primary Outcomes (1)

• Systemic concentration & AUC of study drug

  pre-dose, up to 120 hours after each single dose

Secondary Outcomes (5)

• Adverse events

  from screening, through study day, and up to follow-up visit. Spontaneous reporting

• Systemic concentration & AUC of study drug metabolite

  pre-dose, up to 120 hours after each single dose

• Vital signs

  screening, pre-dose, up-to 15 hours post does, follow-up visit

• 12-lead Electrocardiogram

  screening, pre-dose and up to 8 hours post dose, then at follow-up

• Heamatology, clinical chemistry and Uninalysis

  screening, predose, up-to 8 hours post dose, follow-up

Study Arms (4)

Firategrast XRA

EXPERIMENTAL

Low extended release tablet

Drug: B

Firategrast XRB

EXPERIMENTAL

Medium extended releast tablet

Drug: C

Firategrast XRC

EXPERIMENTAL

High extended release tablet

Drug: D

Firategrast IR

EXPERIMENTAL

Immediate Release reference tablet

Drug: A

Interventions

A DRUG

Single dose treatment IR formulation

Firategrast IR

B DRUG

Low Extended release single dose

Firategrast XRA

C DRUG

Medium extended release formulation

Firategrast XRB

D DRUG

High extended release rate single dose

Firategrast XRC

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18 to 65 yrs inclusive
• Healthy, as determined by study physician
• Capable of giving informed 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 21 units for males, more than 14 units for females)
• Participation in a clinical trial within 90 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 114107 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fumigant 93

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: April 14, 2011
• First Posted: August 29, 2011
• Study Start: April 19, 2010
• Primary Completion: July 6, 2010
• Study Completion: July 6, 2010
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

AU (1)