Status:
COMPLETED
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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. GSK...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01827631
Start Date
May 27 2013
End Date
June 25 2013
Last Update
June 7 2017
Active Locations (1)
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1
GSK Investigational Site
Shanghai, China, 200025