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

Phase 1

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: GSK1605786 capsule

• Registration Number: NCT01827631
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-09
• Study Start: 2013-05-27
• Primary Completion: 2013-06-14
• Study Completion: 2013-06-25
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK1605786 500 mg once daily	GSK1605786 capsule	GSK1605786 500 mg is given once daily in the morning
GSK1605786 500 mg twice daily	GSK1605786 capsule	GSK1605786 500 mg is given twice daily in the morning and in the evening

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Shanghai, China