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Completed

NCT Number: NCT01416363

Healthy Volunteer Study Using 3 Different Formulations of Firategrast

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Firategrast gastro-retentive solution

Drug

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

Primary outcomes

  1. Pharmacokinetic measures for single and repeat dose

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

    Cmax of firategrast

  2. PK measures for single and repeat dose

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

    AUC(0-t) of firategrast

  3. Pharmacokinetic measurements for single and repeat dose

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

    AUC(0-24) of firategrast

Secondary outcomes

  1. Safety & Tolerability in single and repeat doses

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

    Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis

  2. CD34 positive cell count

    Time frame: Part 1 only approx 4 weeks

    as data permit - exploratory measure

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 15, 2011
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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