Japanese Phase I of GSK1605786
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ClinicalTrials.gov Identifier: NCT01611805 |
Recruitment Status
:
Completed
First Posted
: June 5, 2012
Last Update Posted
: June 14, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: GSK1605786 Drug: GSK1605786 Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | July 22, 2010 |
Actual Primary Completion Date : | October 6, 2010 |
Actual Study Completion Date : | October 6, 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: GSK1605786 250mg
Opaque Swedish orange body and cap.
|
Drug: GSK1605786
Opaque Swedish orange body and cap.
|
Placebo Comparator: Placebo
Opaque Swedish orange body and cap.
|
Drug: GSK1605786 Placebo
Opaque Swedish orange body and cap.
|
Experimental: GSK1605786 500mg
Opaque Swedish orange body and cap.
|
Drug: GSK1605786
Opaque Swedish orange body and cap.
|
Experimental: GSK1605786 1000mg
Opaque Swedish orange body and cap.
|
Drug: GSK1605786
Opaque Swedish orange body and cap.
|
Experimental: GSK1605786 500mg in fed
Opaque Swedish orange body and cap.
|
Drug: GSK1605786
Opaque Swedish orange body and cap.
|
- Plasma concentration [ Time Frame: up to 72h post dose ]
- Adverse envents [ Time Frame: up to 72h post dose ]
- Vital signe [ Time Frame: up to 72h post dose ]
- Clinical laboratory [ Time Frame: up to 72h post dose ]
- 12 lead ECG [ Time Frame: up to 72h post dose ]

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Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611805
Australia, New South Wales | |
GSK Investigational Site | |
Randwick, New South Wales, Australia, 2031 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01611805 History of Changes |
Other Study ID Numbers: |
114472 |
First Posted: | June 5, 2012 Key Record Dates |
Last Update Posted: | June 14, 2017 |
Last Verified: | June 2017 |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |