Mobility LimitationPhase 1NCT03065959
A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility
A Phase 1 study testing reldesemtiv in people with Mobility Limitation, run by Astellas Pharma Global Development, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- reldesemtiv
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jun 2017to 10 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has/had > 20% weight loss in the previous 3 months prior to screening.
- Subject has/had chronic medications introduced within 2 weeks prior to screening.
- Subject has/had cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer, carcinoma in situ or cancers that have an excellent prognosis such as early stage breast or prostate cancer).
- Subject has/had a diagnosed neurological conditions or neuromuscular diseases causing impaired muscle function or mobility.
- Subject has current diagnosis of schizophrenia, other psychotic disorders or bipolar disorder.
- Subject has severe and/or uncontrolled medical conditions that could interfere with the study (e.g., severe neurological deficit after stroke, diabetic peripheral neuropathy, respiratory diseases requiring daytime supplemental oxygen, infection, gastrointestinal disorder, uncontrolled pain from osteoarthritis that would limit completion of study procedures or any other nonstable illness).
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, or antibodies to human immunodeficiency virus (HIV) type 1 at screening.
- Subject has/had a surgical procedure requiring general anesthesia within 2 months prior to screening, or a planned surgical procedure requiring general anesthesia during study period.
- Subject is using any nonmedical therapy, or dietary aids/food supplements that have not been at a stable dose for at least 4 weeks prior to baseline and/or are anticipated to change dosing regimen during the study.
- Subject has history of drug/chemical substance or alcohol abuse within 2 years prior to screening.
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio University Heritage College
Athens, Ohio, 45701
Tufts Medical Center
Boston, Massachusetts, 02111-1524
University of Florida
Gainesville, Florida, 32611
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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
- Being tested
- reldesemtiv, Placebo
- Keywords
- CK-2127107, Mobility Limitation, Phase 1b, skeletal muscle fatigue
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reldesemtivDrug
Also called CK-2127107
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: reldesemtiv; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2
Change from period baseline of stair-climb test
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.
Measured: 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
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.
Measured: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start28 Jun 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: Lack of efficacy determined at interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cytokinetics
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065959
- Sponsor's protocol ID
- 3318-CL-3001
- Status last verified
- Oct 2024
- First submitted
- 23 Feb 2017
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03065959
- Acronym / sponsor ID
- 3318-CL-3001
- Conditions
- Mobility Limitation
- Keywords
- CK-2127107, Mobility Limitation, Phase 1b, skeletal muscle fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy determined at interim analysis
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cytokinetics
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CK-2127107, then Placebo | Experimental | Drug: reldesemtiv, Drug: PlaceboParticipants will first receive CK-2127107 tablets (twice daily) for 14 days. After a 14 day wash out period participants will then receive matching placebo. |
| Placebo, then CK-2127107 | Experimental | Drug: reldesemtiv, Drug: PlaceboParticipants will first receive Placebo tablets (twice daily) for 14 days. After a 14 day wash out period participants will then receive matching CK-2127107. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reldesemtivAlso: CK-2127107oral | Drug | CK-2127107, then Placebo, Placebo, then CK-2127107 |
| Placebooral | Drug | CK-2127107, then Placebo, Placebo, then CK-2127107 |
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.
3 secondary outcomes
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
Change from period baseline of stair-climb test
Time frame: 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
Time frame: Baseline, Day 1 and Day 14 of Treatment Periods 1 and 2
Results and safety
The study was stopped early (reason given: Lack of efficacy determined at interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing reldesemtiv in people with Mobility Limitation, run by Astellas Pharma Global Development, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy determined at interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.