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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827631
• Other study ID #: 116416
• 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
• 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 116416 can be found on the GSK Clinical Study Register.