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
The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 3 mg/kg GSK2402968 / placebo |
|
| Cohort 2 | Experimental | 6 mg/kg GSK2402968 / placebo |
|
| Cohort 3 | Experimental | 9 mg/kg GSK2402968 / placebo |
|
| Cohort 4 | Experimental | 12 mg/kg GSK2402968 / placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mg/kg GSK2402968 | Drug | Weekly subcutaneous injection |
| |
| 6 mg/kg GSK2402968 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Pharmacokinetic Variables:AUC, Cmax,t-max, CL/F | 35 days | |
| Incidence of Adverse Events | 35 days | |
| Incidence of Injection Site Reactions | 35 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 | Columbus | Ohio | 43205 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Results for study 114118 can be found on the GSK Clinical Study Register. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Weekly subcutaneous injection |
|
| 9 mg/kg GSK2402968 | Drug | Weekly subcutaneous injection |
|
| 12 mg/kg GSK2402968 | Drug | Weekly subcutaneous injection |
|
| Placebo | Other | Weekly Placebo |
|
| Paris |
| 75651 |
| France |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
Not provided
Not provided