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Following the emergence of an unexpected pharmacodynamic effect, the sponsor has decided to conclude the study early without fully achieving its objective
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Primary Objective:
• To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHR-5154 | Experimental | CHR-5154 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHR-5154 | Drug | CHR-5154 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of volunteers with adverse events | upto 10 days in Single ascending dose phase and 16 days in the Multiple ascending dose phase |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426. | upto 48 hrs post dose | |
| To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state. | Upto 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belfast | BT2 7BA | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 201302 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
Placebo |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |