Clinical trial NCT01416363: Healthy Volunteer Study Using 3 Different Formulations of Firategrast
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: firategrast
pharmacokinetics, modified release, firategrast,
simulated gastro-retentive
pharmacokinetics
healthy volunteers, simulated gastro-retentive
healthy volunteers
modified release
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 38
Sex: MALE
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic measures for single and repeat dose
timeFrame: Part 1: approx. 4 weeks, Part 2: approx 8 days
measure: PK measures for single and repeat dose
timeFrame: Part 1 approx 4 weeks, Part 2 approx 8 days
measure: Pharmacokinetic measurements for single and repeat dose
timeFrame: Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary outcomes:
measure: Safety & Tolerability in single and repeat doses
timeFrame: Part 1: approx. 4 weeks, Part 2: approx 8 days
measure: CD34 positive cell count
timeFrame: Part 1 only approx 4 weeks
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: