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

NCT03065959 | Terminated Phase 1 FDA Drug

• 1 other identifier: 3318-CL-3001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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.

Conditions

Mobility Limitation

Keywords

CK-2127107; Mobility Limitation; Phase 1b; skeletal muscle fatigue

Outcome Measures

Primary Outcomes (1)

• Change from period baseline in sum of the peak torque of 120 contractions

  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.

  Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2

Secondary Outcomes (3)

• Change from period baseline of Short physical performance battery (SPPB) score

  Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2

• Change from period baseline of stair-climb test

  Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2

• Change from period baseline of distance walked assessed by 6-minute walk test

  Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2

Study Arms (2)

CK-2127107, then Placebo

EXPERIMENTAL

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.

Drug: reldesemtiv; Drug: Placebo

Placebo, then CK-2127107

EXPERIMENTAL

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.

Drug: reldesemtiv; Drug: Placebo

Interventions

reldesemtiv DRUG

oral

Also known as: CK-2127107

CK-2127107, then Placebo; Placebo, then CK-2127107

Placebo DRUG

oral

CK-2127107, then Placebo; Placebo, then CK-2127107

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject has a body mass index of 18.5 to 35.0 kg/m2, inclusive.
• Subject has a score of greater than 4 and less than or equal to 10 on a Short physical performance battery (SPPB).
• Subject is able to complete the 6-minute walk test at screening without an assistive device or the help of another person.
• Subject is able to successfully complete the prestudy isokinetic knee extension (120 contractions). These assessments may be repeated once at the investigator's discretion (within the screening window).
• Subject is able to communicate well with the investigator and to understand and comply with the requirements of the study.
• Subject has a mini-mental state examination (MMSE) score of greater than 21 at screening.
• Subject is currently not following a a strenuous weekly exercise regimen.
• A sexually active male subject with female partner(s) of childbearing potential is eligible if:
• Male subject agrees to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration.
• If the male subject has not had a vasectomy or is not sterile as defined below, the male subject's female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continuing throughout study treatment and for 90 days after the male subject receives final study drug administration.
• Male subject must not donate sperm starting at screening and throughout the study period, and for 90 days after the final study drug administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 90 days after the final study drug administration.
• Subject agrees not to participate in another interventional study while participating in the present study, defined as from signing the informed consent form for the current study until completion of the Follow-up visit for this study.

You may not qualify if:

• Subject has had previous exposure to CK-2127107.
• Subject has any of the liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, γ-glutamyl transferase and total bilirubin) above 1.5 times the upper limit of normal at day -1. In such a case, the assessment may be repeated once.
• Subject has an estimated glomerular filtration rate less than 30 mL/min per 1.73 m2 by the Cockcroft-Gault equation at screening.
• Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding seasonal allergies) prior to study drug administration.
• Subject has/had a febrile illness or a symptomatic viral, bacterial (including upper respiratory infections), or fungal (noncutaneous) infection within 1 week prior to day -1.
• Subject has any condition which makes the subject unsuitable for study participation.
• Subject has a serious cardiovascular disease, including a current New York Heart Association class II, class III or IV congestive heart failure or clinically significant valvular disease, history of cardiac arrest, uncontrolled angina or arrhythmia, chronic atrial fibrillation regardless of ventricular rate, persistent atrioventricular conduction block \> first degree, or acute myocardial ischemic condition suspected on the Electrocardiogram (ECG) at screening (e.g., ST-segment elevation, down-sloping ST-segment depressions \> 2 mm).
• Subject has myocardial infarction or other acute coronary syndrome, major heart surgery (i.e.,valve replacement or bypass surgery), stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months prior to screening.
• Subject has any of the following, with or without blood pressure medication: a pulse \< 40 or \> 100 bpm; mean systolic blood pressure \>160 mmHg; mean diastolic blood pressure \> 100 mmHg (based on the measurements taken in triplicate after subject has been resting in seated position for 5 minutes; pulse will be measured automatically) at day 1. These assessments may be repeated once at the investigator's discretion (within the screening window).
• Subject has used the following drugs:
• Strong cytochrome P450 (CYP) 3A4 inhibitor (e.g., itraconazole, clarithromycin; within 14 days prior to day 1
• CYP3A4 inducer (e.g., barbiturates, rifampin) within 14 days prior to day 1.
• Any medications known to affect physical function or muscle mass including androgen supplements, anti-androgens (such as luteinizing hormone-releasing hormone \[LHRH\] agonist, anti-estrogen \[tamoxifen, etc\],.), recombinant human growth hormone \[rhGH\] insulin, oral beta adrenergic agonists, megestrol acetate, dronabinol, metformin or other drugs) which might influence physical function or muscle mass within 6 weeks prior to screening.
• Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to screening.
• Subject has/had hemoglobin concentration below 10.0 g/dL at screening.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Cytokinetics: collaborator

Study Sites (5)

University of Florida

Gainesville, Florida, 32611, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111-1524, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Ohio University Heritage College

Athens, Ohio, 45701, United States

Location

Related Links

• Link to results on the Astellas Clinical Study Results website.

MeSH Terms

Conditions

Mobility Limitation

Interventions

reldesemtiv

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: June 28, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)