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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: GSK1605786 capsule

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GSK1605786 500 mg once daily; GSK1605786 500 mg is given once daily in the morning	Drug: GSK1605786 capsule; Swedish Orange, size 0, hard gelatine capsules
EXPERIMENTAL: GSK1605786 500 mg twice daily; GSK1605786 500 mg is given twice daily in the morning and in the evening	Drug: GSK1605786 capsule; Swedish Orange, size 0, hard gelatine capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events (AEs)	AEs occur during the study	up to 21 days, from the first dose until the follow-up visit
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
lab assessment	Hematology/Clinical Chemistry/Urinalysis test	Day 17 prior to leaving the clinic

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2013
• Primary Completion (ACTUAL): June 14, 2013
• Study Completion (ACTUAL): June 25, 2013

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (ESTIMATE): April 9, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: pharmacokinetics; healthy; Chinese subjects; GSK1605786; CCR9 receptor antagonist
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 116416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: 116416
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register