Clinical Trial: Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I/II Study of DS-5141b: Open-label Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Brief Summary: This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) and to determine the dosage for subsequent studies.

Detailed Summary:
Sponsor: Daiichi Sankyo Co., Ltd.

Current Primary Outcome:

• number and severity of adverse events [ Time Frame: week 0 (baseline) to week 12 ]
  number and severity of treatment emergent adverse events
• Cmax maximum concentration [ Time Frame: week 12 ]
  pharmacokinetic profile
• AUC area under the curve [ Time Frame: week 12 ]
  pharmacokinetic profile
• Tmax time of maximum concentration [ Time Frame: week 12 ]
  pharmacokinetic profile
• T1/2 half-life [ Time Frame: week 12 ]
  pharmacokinetic profile

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Daiichi Sankyo Inc.

Dates:
Date Received: January 26, 2016
Date Started: October 2015
Date Completion: September 2017
Last Updated: August 22, 2016
Last Verified: August 2016