Expired Study
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Columbus, Ohio 43205


Purpose:

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


Criteria:

Inclusion Criteria: - Duchenne muscular dystrophy resulting from a mutation in the DMD gene, confirmed by a sponsor approved DNA diagnostic technique covering all DMD gene exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe Amplification), CGH (Comparative Genomic Hybridisation), SCAIP (Single Condition Amplification/Internal Primer) or H-RMCA (High-Resolution Melting Curve Analysis), and correctable by treatment with GSK2402968. - Age 9 years old or greater at Screening; - Male; - Non-ambulant (at least 1 year in a wheelchair) within the last 4 years; - Life expectancy at least three years; - Willingness and ability to comply with all protocol requirements and procedures; - QTc <450msec (based on single or average QTc value of triplicate ECGs obtained over a brief recording period). Note: QTc may be either QTcB or QTcF, machine read or manual overread; - Subjects must be willing to use adequate contraception (condoms or abstinence), from Screening until at least 5 months after the last dose of study drug; - Informed assent and/or consent in writing signed by the subject and/or parent(s)/legal guardian (according to local regulations). Exclusion Criteria: - Any additional mutation (such as an additional missing exon for DMD) that cannot be treated with GSK2402968; - Current or history of liver or renal disease; - Acute illness within 4 weeks of anticipated administration of study medication, which may interfere with study assessments; - Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs, idebenone or other forms of Coenzyme Q10, within 6 months of the first administration of study medication; - Start of glucocorticosteroids within 6 months or non-stable use of glucocorticosteroids within 3 months of the anticipated first administration of study medication; - Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test at Screening; - Symptomatic cardiomyopathy; - Use of alcohol from Screening through to the 1 month Follow-up visit ; - Any Child in Care.


NCT ID:

NCT01128855


Primary Contact:

Study Director
GSK Clinical Trials
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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