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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GSK1605786 capsule
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GSK1605786 500 mg once daily

GSK1605786 500 mg twice daily

Arm Description

GSK1605786 500 mg is given once daily in the morning

GSK1605786 500 mg is given twice daily in the morning and in the evening

Outcomes

Primary Outcome Measures

Cmax
maximum concentration after single dose and repeat dose
AUC(0-τ)
area under the concentration time curve during steady state

Secondary Outcome Measures

adverse events (AEs)
AEs occur during the study
vital signs
blood pressure, pulse rate, respiratory rate and temperature
lab assessment
Hematology/Clinical Chemistry/Urinalysis test

Full Information

First Posted
April 5, 2013
Last Updated
June 5, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01827631
Brief Title
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Official Title
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 27, 2013 (Actual)
Primary Completion Date
June 14, 2013 (Actual)
Study Completion Date
June 25, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK1605786 500 mg once daily
Arm Type
Experimental
Arm Description
GSK1605786 500 mg is given once daily in the morning
Arm Title
GSK1605786 500 mg twice daily
Arm Type
Experimental
Arm Description
GSK1605786 500 mg is given twice daily in the morning and in the evening
Intervention Type
Drug
Intervention Name(s)
GSK1605786 capsule
Intervention Description
Swedish Orange, size 0, hard gelatine capsules
Primary Outcome Measure Information:
Title
Cmax
Description
maximum concentration after single dose and repeat dose
Time Frame
up to 72 hour post dose
Title
AUC(0-τ)
Description
area under the concentration time curve during steady state
Time Frame
up to 24 hour post last dose
Secondary Outcome Measure Information:
Title
adverse events (AEs)
Description
AEs occur during the study
Time Frame
up to 21 days, from the first dose until the follow-up visit
Title
vital signs
Description
blood pressure, pulse rate, respiratory rate and temperature
Time Frame
before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic
Title
lab assessment
Description
Hematology/Clinical Chemistry/Urinalysis test
Time Frame
Day 17 prior to leaving the clinic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116416
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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

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