NCT03065959

A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility

A Phase 1b Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 65 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of CK-2127107 versus placebo on skeletal muscle fatigue assessed as change from baseline versus 14 days of treatment in sum of peak torque during isokinetic knee extensions. This study will also assess the effects of CK-2127107 on physical performance via a short physical performance battery (SPPB), stair-climb test and 6 minute walk test.

Detailed description

Enrolled participants will be randomized to receive either CK-2127107 or Placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 14 days separated by a washout period of 14 days.

Conditions

• Mobility Limitation

Interventions

Type	Name	Description
DRUG	reldesemtiv	oral
DRUG	Placebo	oral

Timeline

• Start date: 2017-06-28
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2017-02-28
• Last updated: 2024-10-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study