NCT02056808

A Phase 1b Study of SMT C1100 in Subjects With Duchenne Muscular Dystrophy (DMD)

SMT C1100 - A Phase 1b, Open-label, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Paediatric Patients With Duchenne Muscular Dystrophy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Summit Therapeutics · Industry
• Sex: Male
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether increasing doses of SMT C1100 are safe, well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular Dystrophy (DMD).

Detailed description

Primary Objective: To determine the safety and tolerability of single and multiple oral doses of SMT C1100 in patients with Duchenne Muscular Dystrophy (DMD). Secondary Objectives: To determine the single and multiple oral dose pharmacokinetics of SMT C1100 and its metabolites in patients with DMD.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	SMT C1100	Comparison of safety and pharmacokinetic of different dosages of drug

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2014-02-06
• Last updated: 2014-08-27

Locations

4 sites across 1 country: United Kingdom