A Study of TAS-205 for Duchenne Muscular Dystrophy

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Able to give an informed consent. If applicable, able to give an informed assent.

• Male and >= 5 years and < 16 years of age.

• Bodyweight of >= 15.0 kg and < 75.0 kg.

• Phenotypic evidence of DMD.

• Able to take tablets.

• If taking oral glucocorticosteroids no significant change in total daily dosage or dosing regimen after enrollment.

• Confirmed the urinary PD marker over its criteria.

• Able to follow the study protocol.

Exclusion Criteria:

• Current diagnosis or history of any drug allergy.

• A forced vital capacity (FVC) < 50% of predicted value.

• A left ventricular ejection fraction (EF) < 50% or fractional shortening (FS) < 25% based on echocardiogram (ECHO).

• Ongoing immunosuppressive therapy (other than corticosteroids).

• With severe disease such as hepatic disease, kidney disease and others.

• With any systemic allergic disease or any chronic inflammatory disease.

• Treated with any other investigational agents within 90 days.

• Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test.