Clinical trial NCT01424462: Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
Official title: An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: healthy volunteers
firategrast
Pharmacokinetics
modified release
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies.

Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 65 yrs inclusive
* Healthy, as determined by study physician
* Capable of giving informed 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 21 units for males, more than 14 units for females)
* Participation in a clinical trial within 90 days of scheduled first dose

Primary outcomes:
measure: Systemic concentration & AUC of study drug
timeFrame: pre-dose, up to 120 hours after each single dose
Secondary outcomes:
measure: Adverse events
timeFrame: from screening, through study day, and up to follow-up visit. Spontaneous reporting
measure: Systemic concentration & AUC of study drug metabolite
timeFrame: pre-dose, up to 120 hours after each single dose
measure: Vital signs
timeFrame: screening, pre-dose, up-to 15 hours post does, follow-up visit
measure: 12-lead Electrocardiogram
timeFrame: screening, pre-dose and up to 8 hours post dose, then at follow-up
measure: Heamatology, clinical chemistry and Uninalysis
timeFrame: screening, predose, up-to 8 hours post dose, follow-up
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: