Japanese Phase I of GSK1605786

Study Overview
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Brief Summary
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This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.

Official Title
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A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: GSK1605786
* Drug: GSK1605786 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese as Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent. Body weight =>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive). Exclusion Criteria: - Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1605786 250mg<br>Opaque Swedish orange body and cap. | Drug: GSK1605786<br>* Opaque Swedish orange body and cap.<br>|
| Placebo Comparator: Placebo<br>Opaque Swedish orange body and cap. | Drug: GSK1605786 Placebo<br>* Opaque Swedish orange body and cap.<br>|
| Experimental: GSK1605786 500mg<br>Opaque Swedish orange body and cap. | Drug: GSK1605786<br>* Opaque Swedish orange body and cap.<br>|
| Experimental: GSK1605786 1000mg<br>Opaque Swedish orange body and cap. | Drug: GSK1605786<br>* Opaque Swedish orange body and cap.<br>|
| Experimental: GSK1605786 500mg in fed<br>Opaque Swedish orange body and cap. | Drug: GSK1605786<br>* Opaque Swedish orange body and cap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration |  | up to 72h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse envents |  | up to 72h post dose | 
| Vital signe |  | up to 72h post dose | 
| Clinical laboratory |  | up to 72h post dose | 
| 12 lead ECG |  | up to 72h post dose |