A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03065959|
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : May 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Mobility Limitation||Drug: CK-2127107 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||June 28, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: CK-2127107, then Placebo
Participants will first receive CK-2127107 tablets (twice daily) for 14 days. After a 14 day wash out period participants will then receive matching placebo.
Experimental: Placebo, then CK-2127107
Participants will first receive Placebo tablets (twice daily) for 14 days. After a 14 day wash out period participants will then receive matching CK-2127107.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065959
|Contact: Astellas Pharma Global Developmentfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111-1524|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110-1010|
|United States, North Carolina|
|Wake Forest University School of Medicine||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Ohio University Heritage College||Recruiting|
|Athens, Ohio, United States, 45701|
|Study Director:||Senior Medical Director||Astellas Pharma Global Development, Inc.|