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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Astellas Pharma Global Development, Inc.

Current Primary Outcome: Change from period baseline in sum of the peak torque of 120 contractions [ Time Frame: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2 ]

Peak torque measurements will be obtained with the participants seated and the knee extended through a determined range of motion. Peak torque (Nm) will be measured at 120°/second with 120 isokinetic contractions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from period baseline of Short physical performance battery (SPPB) score [ Time Frame: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2 ]
    Each of the 3 performance measures will be assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the test. A summary score (range 0-12) will be subsequently calculated by adding the 3 scores.
  • Change from period baseline of stair-climb test [ Time Frame: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2 ]
    Participants will be asked to ascend a set of 10 stairs. The participants will be asked to ascend the stairs 1 step at a time as quickly as the participant can while remaining safe. Time will be recorded as seconds.
  • Change from period baseline of distance walked assessed by 6-minute walk test [ Time Frame: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2 ]
    Participants will be instructed to walk as far as possible in 6 minutes, walking back and forth around the turn points. The distance will be recorded in meters.


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: February 23, 2017
Date Started: May 31, 2017
Date Completion: June 25, 2018
Last Updated: April 6, 2017
Last Verified: April 2017