Japanese Phase I of GSK1605786
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
GSK1605786
GSK1605786 Placebo
Sponsored by
About this trial
This is an interventional other trial for Crohn's Disease
Eligibility Criteria
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)
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
GSK1605786 250mg
Placebo
GSK1605786 500mg
GSK1605786 1000mg
GSK1605786 500mg in fed
Arm Description
Opaque Swedish orange body and cap.
Opaque Swedish orange body and cap.
Opaque Swedish orange body and cap.
Opaque Swedish orange body and cap.
Opaque Swedish orange body and cap.
Outcomes
Primary Outcome Measures
Plasma concentration
Secondary Outcome Measures
Adverse envents
Vital signe
Clinical laboratory
12 lead ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01611805
Brief Title
Japanese Phase I of GSK1605786
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 22, 2010 (Actual)
Primary Completion Date
October 6, 2010 (Actual)
Study Completion Date
October 6, 2010 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1605786 250mg
Arm Type
Experimental
Arm Description
Opaque Swedish orange body and cap.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Opaque Swedish orange body and cap.
Arm Title
GSK1605786 500mg
Arm Type
Experimental
Arm Description
Opaque Swedish orange body and cap.
Arm Title
GSK1605786 1000mg
Arm Type
Experimental
Arm Description
Opaque Swedish orange body and cap.
Arm Title
GSK1605786 500mg in fed
Arm Type
Experimental
Arm Description
Opaque Swedish orange body and cap.
Intervention Type
Drug
Intervention Name(s)
GSK1605786
Intervention Description
Opaque Swedish orange body and cap.
Intervention Type
Drug
Intervention Name(s)
GSK1605786 Placebo
Intervention Description
Opaque Swedish orange body and cap.
Primary Outcome Measure Information:
Title
Plasma concentration
Time Frame
up to 72h post dose
Secondary Outcome Measure Information:
Title
Adverse envents
Time Frame
up to 72h post dose
Title
Vital signe
Time Frame
up to 72h post dose
Title
Clinical laboratory
Time Frame
up to 72h post dose
Title
12 lead ECG
Time Frame
up to 72h post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
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
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Japanese Phase I of GSK1605786
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