Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1605786 500 mg once daily | Experimental | GSK1605786 500 mg is given once daily in the morning |
|
| GSK1605786 500 mg twice daily | Experimental | GSK1605786 500 mg is given twice daily in the morning and in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1605786 capsule | Drug | Swedish Orange, size 0, hard gelatine capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum concentration after single dose and repeat dose | up to 72 hour post dose |
| AUC(0-Ï„) | area under the concentration time curve during steady state | up to 24 hour post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events (AEs) | AEs occur during the study | up to 21 days, from the first dose until the follow-up visit |
| vital signs | blood pressure, pulse rate, respiratory rate and temperature |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shanghai | 200025 | China |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study 116416 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116416 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic |
| lab assessment | Hematology/Clinical Chemistry/Urinalysis test | Day 17 prior to leaving the clinic |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116416 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007410 | Intestinal Diseases |