Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

Study Overview
=================
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.

Official Title
-----------------
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: GSK1605786 capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1605786 500 mg once daily<br>GSK1605786 500 mg is given once daily in the morning | Drug: GSK1605786 capsule<br>* Swedish Orange, size 0, hard gelatine capsules<br>|
| Experimental: GSK1605786 500 mg twice daily<br>GSK1605786 500 mg is given twice daily in the morning and in the evening | Drug: GSK1605786 capsule<br>* Swedish Orange, size 0, hard gelatine capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum concentration after single dose and repeat dose | up to 72 hour post dose | 
| AUC(0-τ) | area under the concentration time curve during steady state | up to 24 hour post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events (AEs) | AEs occur during the study | up to 21 days, from the first dose until the follow-up visit | 
| vital signs | blood pressure, pulse rate, respiratory rate and temperature | before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic | 
| lab assessment | Hematology/Clinical Chemistry/Urinalysis test | Day 17 prior to leaving the clinic | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics