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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01611805 |
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Date of registration:
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12/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Japanese Phase I of GSK1605786
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Scientific 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 |
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Date of first enrolment:
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July 22, 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01611805 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion 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)
Age minimum:
20 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: GSK1605786 Placebo
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Drug: GSK1605786
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Primary Outcome(s)
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Plasma concentration
[Time Frame: up to 72h post dose]
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Secondary Outcome(s)
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Clinical laboratory
[Time Frame: up to 72h post dose]
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Vital signe
[Time Frame: up to 72h post dose]
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Adverse envents
[Time Frame: up to 72h post dose]
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12 lead ECG
[Time Frame: up to 72h post dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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