Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
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Details and patient eligibility
About
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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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