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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01827631
Other study ID # 116416
Secondary ID
Status Completed
Phase Phase 1
First received April 5, 2013
Last updated June 5, 2017
Start date May 27, 2013
Est. completion date June 25, 2013

Study information

Verified date June 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date June 25, 2013
Est. primary completion date June 14, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK1605786 capsule
Swedish Orange, size 0, hard gelatine capsules

Locations

Country Name City State
China GSK Investigational Site Shanghai

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax maximum concentration after single dose and repeat dose up to 72 hour post dose
Primary AUC(0-t) area under the concentration time curve during steady state up to 24 hour post last dose
Secondary adverse events (AEs) AEs occur during the study up to 21 days, from the first dose until the follow-up visit
Secondary 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
Secondary lab assessment Hematology/Clinical Chemistry/Urinalysis test Day 17 prior to leaving the clinic
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