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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-27

Study Completion Date

2013-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK1605786 500 mg once daily

GSK1605786 500 mg is given once daily in the morning

Group Type EXPERIMENTAL

GSK1605786 capsule

Intervention Type DRUG

Swedish Orange, size 0, hard gelatine capsules

GSK1605786 500 mg twice daily

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

Group Type EXPERIMENTAL

GSK1605786 capsule

Intervention Type DRUG

Swedish Orange, size 0, hard gelatine capsules

Interventions

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GSK1605786 capsule

Swedish Orange, size 0, hard gelatine capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Shanghai, , China

Site Status

Countries

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China

Study Documents

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