Crohn's Disease
Conditions
Keywords
healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics
Brief summary
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
Interventions
DRUGGSK1605786 capsule
Swedish Orange, size 0, hard gelatine capsules
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG * Male or female between 18 and 45 years of age * Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2
Exclusion criteria
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening * Current or chronic history of liver disease, or known hepatic or biliary * A positive test for HIV antibody at screening * Known coeliac disease and positive serologic testing for anti-tTG antibodies * A positive pre-study drug/alcohol screen * Lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 72 hour post dose | maximum concentration after single dose and repeat dose |
| AUC(0-τ) | up to 24 hour post last dose | area under the concentration time curve during steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events (AEs) | up to 21 days, from the first dose until the follow-up visit | AEs occur during the study |
| vital signs | before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic | blood pressure, pulse rate, respiratory rate and temperature |
| lab assessment | Day 17 prior to leaving the clinic | Hematology/Clinical Chemistry/Urinalysis test |
Countries
China
Outcome results
None listed