NCT02246478

A Study of TAS-205 for Duchenne Muscular Dystrophy

A Phase I Study of Single and Multiple Doses of TAS-205 in Patients With Duchenne Muscular Dystrophy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and loss of upper body function. The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 after single and multiple doses in DMD patients. It is also evaluated if TAS-205 affects the urinary excretion of pharmacodynamic (PD) marker in DMD patients.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	TAS-205	* Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals * Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
DRUG	Placebo	* Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals * Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2014-09-22
• Last updated: 2021-06-04
• Results posted: 2021-06-04

Locations

1 site across 1 country: Japan