Japanese Phase I of GSK1605786
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: GSK1605786 Drug: GSK1605786 Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
- Plasma concentration [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]
- Adverse envents [ Time Frame: up to 72h post dose ] [ Designated as safety issue: Yes ]
- Vital signe [ Time Frame: up to 72h post dose ] [ Designated as safety issue: Yes ]
- Clinical laboratory [ Time Frame: up to 72h post dose ] [ Designated as safety issue: Yes ]
- 12 lead ECG [ Time Frame: up to 72h post dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | July 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders 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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01611805 History of Changes |
| Other Study ID Numbers: | 114472 |
| Study First Received: | April 12, 2012 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Australia: Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013