Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
healthy volunteers, firategrast, Pharmacokinetics, modified release
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic concentration & AUC of study drug | pre-dose, up to 120 hours after each single dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Blood samples for standard clinical safety monitoring, and unine samples |
Countries
Australia
Outcome results
None listed