Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
firategrast, pharmacokinetics, modified release, firategrast,, simulated gastro-retentive, pharmacokinetics, healthy volunteers, simulated gastro-retentive, healthy volunteers, modified release
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.
Interventions
DRUGFirategrast immediate release tablet
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.
DRUGFirategrast modified release tablet
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
DRUGFirategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic measures for single and repeat dose | Part 1: approx. 4 weeks, Part 2: approx 8 days | Cmax of firategrast |
| PK measures for single and repeat dose | Part 1 approx 4 weeks, Part 2 approx 8 days | AUC(0-t) of firategrast |
| Pharmacokinetic measurements for single and repeat dose | Part 1: approx 4 weeks, Part 2: approx 8 days | AUC(0-24) of firategrast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety & Tolerability in single and repeat doses | Part 1: approx. 4 weeks, Part 2: approx 8 days | Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis |
| CD34 positive cell count | Part 1 only approx 4 weeks | as data permit - exploratory measure |
Countries
Australia
Outcome results
None listed