Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT02662582
A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Reldesemtiv in people with Chronic Obstructive Pulmonary Disease (COPD), run by Astellas Pharma Global Development, Inc. at 2 sites in United States.
Trial summary
The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with integrated electrocardiogram (ECG). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- 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
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2016to 8 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a body mass index (BMI) of 18-35 kg/m2 inclusive.
- Subject must have all of the following:
- Clinical diagnosis of moderate to severe COPD, with a postbronchodilator FEV1/FVC ratio < 70% and 30% ≤ FEV1 < 65% predicted at screening. The predicted values for normal spirometry will be those recommended by the American Thoracic Society (ATS) / European Respiratory Society (ERS) [Miller et al, 2005].
- General stable health with no change in medication (including non-COPD agents and dietary aids/food supplements) within 2 weeks prior to screening, no systemic corticosteroid administration (topical or inhaled corticosteroids are allowed) within 6 weeks prior to screening, no exacerbations or hospitalization within 6 weeks prior to screening.
- Current or ex-smokers with a smoking history of at least 10 pack years.
- Grade of 2 or 3 on the Modified Medical Research Council (mMRC) Dyspnea Scale at screening:
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- Grade 2: walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level.
- Grade 3: stops for breath after walking about 100 meters or after a few minutes on the level.
- Subject is able to complete technically acceptable respiratory muscle strength tests, spirometry, physical performance test and exercise tests.
- Female subject must either:
- Be of non-child bearing potential: Postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile.
- Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the last dose, and have a negative serum pregnancy test at screening, and, if heterosexually active, agree to consistently use 2 forms of highly-effective birth control (at least 1 of which must be a barrier method) starting at screening, throughout the study, and for 28 days after the last dose.
- Female subject must agree not to breastfeed starting at screening and throughout the study and for 28 days after the last dose.
- Female subject must not donate ova starting at screening, throughout the study and for 28 days after the last dose.
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective form of contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at screening, and continuing throughout the study and for 90 days after the last dose.
- Male subject must not donate sperm starting at screening, throughout the study and for 90 days after the last dose.
- Subject agrees not to participate in another interventional study from screening through the follow-up visit (FUV) of the study.
Who cannot join
- Subject has previously enrolled in a clinical study of CK-2127107.
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening. A significant abnormality is defined as an abnormality which, in the opinion of the investigator, may (i) put the subject at risk because of participation in the study, (ii) influence the results of the study or (iii) cause concern regarding the subject's ability to participate in the study.
- Subject has any of the liver function tests (LFTs; i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], γ-glutamyl transferase [GGT] and/or total bilirubin [TBL]) above 1.5 times the upper limit of normal (ULN) at screening. These assessments may be repeated once at the investigator's discretion (within the screening window).
- Subject has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 by the Cockcroft-Gault equation at screening.
- Subject has a serious cardiovascular disease, including a current New York Heart Association (NYHA) class III or IV congestive heart failure or clinically significant valvular disease, history of cardiac arrest, uncontrolled angina or arrhythmia, untreated serious conduction disorder (e.g., third-degree heart block), or acute myocardial ischemic condition suspected on the ECG at screening (e.g., ST-segment elevation, ST-segment depressions > 2 mm).
- Subject has had a 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 6 months prior to screening.
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- Subject has known active tuberculosis.
- Subject has undergone thoracotomy with pulmonary resection (except for sub-lobar resection).
- Subject has resting pulse < 40 bpm or > 100 bpm; resting systolic blood pressure > 160 mm Hg or < 90 mm Hg; resting diastolic blood pressure > 100 mm Hg at screening. These assessments may be repeated once at the investigator's discretion (within the screening window).
- Subject desaturates to SpO2 < 85% for at least 1 minute on screening IET.
- Subject has a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea/shortness of breath (considered to be due to COPD), such as arthritis in the leg, angina pectoris, heart failure, claudication or morbid obesity.
- Subject has a CWR cycle ergometry endurance time less than 4 or greater than 8 minutes after WR adjustment procedures.
- Subject has used the following drugs within 14 days prior to day -1:
- Strong cytochrome P450 (CYP)3A4 inhibitor (e.g., itraconazole, clarithromycin).
- Strong CYP3A4 inducer (e.g., barbiturates, rifampin).
- Subject has hemoglobin (Hb) concentration below 10.0 g/dL at screening.
- Subject has a 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 giving a history of asthma, allergic rhinitis or atopy shall be evaluated by the investigator to determine whether the subject's predominant diagnosis is COPD rather than asthma.
- Subject has neurological conditions or neuromuscular diseases that are causing impaired muscle function or mobility.
- Subject has a current diagnosis of schizophrenia, other psychotic disorders or bipolar disorder.
- Subject in the active phase of pulmonary rehabilitation or had completed pulmonary rehabilitation or exercise training within the 13 weeks prior to screening.
- Subject has severe and/or uncontrolled medical conditions that could interfere with the study (e.g., severe neurological deficit after stroke, developed diabetic peripheral neuropathy, respiratory diseases requiring daytime supplemental oxygen, infection, gastrointestinal disorder, uncontrolled pain or any other non-stable illness) as judged by the medical investigator.
- Subject has a known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection.
- Subject has a history of alcoholism or drug/chemical substance abuse within 2 years prior to screening.
- Subject has used any medications known to affect physical function or muscle mass including androgen supplements, anti-androgens (such as luteinizing hormone-releasing hormone [LHRH] agonists), anti-estrogen (tamoxifen, etc.), recombinant human growth hormone (rhGH), insulin, oral beta adrenergic agonists, megestrol acetate, dronabinol, metformin or other drugs which, in the opinion of the investigator, might influence physical function or muscle mass within 6 weeks prior to screening.
- Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 28 days or 5 half-lives whichever is longer, prior to the initiation of screening.
- Subject has any other condition that in the opinion of the investigator precludes the subject's participation in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site US10003
Pittsburgh, Pennsylvania, 15213
Site US10001
Torrance, California, 90502
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Two Period, Crossover Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with integrated electrocardiogram (ECG). The time to intolerance was assessed by a stopwatch and verified from electronic recordings of the cycle ergometer.
This study assessed cardiopulmonary and neuromuscular effects of CK-2127107 relative to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.
Read the detailed description
Enrolled participants were randomly assigned to 1 of 2 treatment sequences and received both CK-2127107 and matching placebo over 2 treatment periods.
- Being tested
- Reldesemtiv, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, CK-2127107, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| CK-2127107 1000 mg, then placebo | Experimental | Participants received CK-2127107 500 milligram (mg), orally, twice daily for 2 weeks in treatment period 1 followed by matching placebo orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. Receives: Drug: Reldesemtiv; Drug: Placebo |
| Placebo, then CK-212710 1000 mg | Experimental | Participants received matching placebo orally, twice daily for 2 weeks in treatment period 1 followed by CK-2127107 500 mg in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. 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 at Week 2 in Constant Work Rate (CWR) Endurance Time Relative to Placebo
The CWR defines how long it takes until the participant reaches symptom limitations while simultaneously being monitored and is called "CWR time to intolerance," which determined the "CWR endurance time". Positive change indicates an improvement from baseline (i.e., a favorable outcome).
Measured: Baseline and week 2 of each treatment period
Secondary outcomes (25)
Change From Period Baseline at Week 2 in Oxygen Uptake (VO2)
VO2 was defined as volume of O2 extracted from inspired air in a given period of time. VO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilation (VE)
VE was defined as volume of gas exhaled from the lungs in 1 minute, also called 'ventilation' or 'minute ventilation. VE was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)
VE/VCO2 was a ratio of VE to VCO2. It is a dimensionless quantity. This ratio indicates how many liters of air exhaled were breathed to eliminate 1 liter of CO2. VE/VCO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Inspiratory Capacity (IC) Change From Peak to Rest
IC was defined as the volume of air that can be inspired after a normal expiration; it is the sum of the tidal volume (VT) and the IRV.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Perceived Exertion for Dyspnea and Leg Discomfort (BORG CR10)
The Borg Scale (Borg CR10) is a simple 10-item method of rating perceived exertion and collects information on perceived exertion in an individual's rating of exercise intensity. Participants were asked to use this scale to rate the intensity of their breathing and leg discomfort before, during, and after exercise. Scores range from 0 (Complete Rest) to 10 (Extremely Hard (almost maximal)). BORG CR10 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Respiratory Exchange Ratio (RER)
The respiratory exchange ratio is equal to the VCO2 / VO2 [RER = VCO2 (L/min) / VO2 (L/min)]. RER was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Carbon Dioxide Output (VCO2)
VCO2 was defined as volume of CO2 exhaled from the body per unit of time; also called the rate of elimination of CO2. VCO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in End-tidal PCO2 (PETCO2)
PETCO2 was defined as partial pressure of carbon dioxide in the expired gas at the end of an exhalation. This represents the mean partial pressure of carbon dioxide in the pulmonary alveoli. PETCO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in End-tidal PO2 (PETO2)
PETO2 was defined as Partial pressure of oxygen in the expired gas at the end of an exhalation. This represents the mean partial pressure of oxygen in the pulmonary alveoli. PETO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Tidal Volume (VT)
VT was defined as tidal volume is the volume of gas exhaled in each respiratory cycle. Tidal volume is typically measured as an average value over several respiratory cycles, and is expressed in liters. VT was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Breathing Frequency (Bf)
Bf was defined as the number of breaths (i.e., an entire inspiratory and expiratory respiratory cycle) per minute. Bf was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Inspiratory Capacity (IC)
IC was defined as the volume of air that can be inspired after a normal expiration; it is the sum of the VT and the IRV. IC was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline to Week 2 in Inspiratory Reserve Volume (IRV)
The Inspiratory reserve volume was equal to VT - IC measured in liters [IRV (L) = VT (L) - IC (L)]. IRV was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilatory Reserve (VE/MVV)
VE/MVV provides the rate of expired ventilation to the capacity. VE/MVV was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Heart Rate (HR)
HR was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Systolic Blood Pressure (SBP)
SBP was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Diastolic Blood Pressure (DBP)
DBP was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Arterial Oxygen Saturation From Pulse Oximetry (SpO2)
SPO2 was defined as the noninvasive estimation of arterial hemoglobin (Hb) oxygen saturation, using a device that utilizes the combined principles of spectrophotometry and pulse plethysmography. SPO2 was reported at isotime and peak exercise during CWR test.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Forced Vital Capacity (FVC)
Change From Period Baseline in FVC was reported.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Forced Expiratory Volume 1 (FEV1)
Change From Period Baseline in FEV1 was reported.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in FVC/FEV1 Ratio
Change From Period Baseline in FVC/FEV1 Ratio was reported.
Measured: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Activation of Accessory Respiratory Muscles
Activation of accessory respiratory muscles was assessed by electromyogram. Data was reported at peak and isotime.
Measured: Baseline and week 2 of each treatment period
Number of Participants With Treatment Emergent Adverse Events
TEAEs were defined as any AE that started or worsened in severity after the first dose of study drug up to 14 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG data, physical examination) an AE only if the abnormality meets 1 of the following criteria: Induces clinical signs or symptoms, Requires active intervention, Requires interruption or discontinuation of study drug, The abnormality or test value is clinically significant in the opinion of the inves
Measured: From first dose of study drug up to 14 days after last dose of study drug (8 weeks)
Plasma Concentration of CK-2127107 at Day 1 Predose, Day 14 Lowest Concentration (Ctrough), and Day 14 Concentration Predose 6 Hours (C6h)
Plasma concentration of CK-2127107 was reported.
Measured: Day 1 predose, day 14 Ctrough, day 14 C6h
Plasma Concentration of CK-2127106 (Metabolite of CK-2127107) at Day 1 Predose, Day 14 Ctrough, Day 14 C6h
Plasma concentration of CK-2127106 (metabolite of CK-2127107) was reported.
Measured: Day 1 predose, day 14 Ctrough, day 14 C6h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start30 Jun 2016
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT02662582
- Sponsor's protocol ID
- 3318-CL-3002
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2016
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled, Two Period, Crossover Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02662582
- Acronym / sponsor ID
- 3318-CL-3002
- Keywords
- Chronic Obstructive Pulmonary Disease, CK-2127107, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cytokinetics
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Posted 5 Feb 2021
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 was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with integrated electrocardiogram (ECG). The time to intolerance was assessed by a stopwatch and verified from electronic recordings of the cycle ergometer.
This study assessed cardiopulmonary and neuromuscular effects of CK-2127107 relative to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.
Detailed description
Enrolled participants were randomly assigned to 1 of 2 treatment sequences and received both CK-2127107 and matching placebo over 2 treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CK-2127107 1000 mg, then placebo | Experimental | Drug: Reldesemtiv, Drug: PlaceboParticipants received CK-2127107 500 milligram (mg), orally, twice daily for 2 weeks in treatment period 1 followed by matching placebo orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. |
| Placebo, then CK-212710 1000 mg | Experimental | Drug: Reldesemtiv, Drug: PlaceboParticipants received matching placebo orally, twice daily for 2 weeks in treatment period 1 followed by CK-2127107 500 mg in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject has a body mass index (BMI) of 18-35 kg/m2 inclusive.
- Subject must have all of the following:
- Subject is able to complete technically acceptable respiratory muscle strength tests, spirometry, physical performance test and exercise tests.
- Female subject must either:
- Female subject must agree not to breastfeed starting at screening and throughout the study and for 28 days after the last dose.
Key exclusion criteria (27 listed)
- Subject has previously enrolled in a clinical study of CK-2127107.
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening. A significant abnormality is defined as an abnormality which, in the opinion of the investigator, may (i) put the subject at risk because of participation in the study, (ii) influence the results of the study or (iii) cause concern regarding the subject's ability to participate in the study.
- Subject has any of the liver function tests (LFTs; i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], γ-glutamyl transferase [GGT] and/or total bilirubin [TBL]) above 1.5 times the upper limit of normal (ULN) at screening. These assessments may be repeated once at the investigator's discretion (within the screening window).
- Subject has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 by the Cockcroft-Gault equation at screening.
- Subject has a serious cardiovascular disease, including a current New York Heart Association (NYHA) class III or IV congestive heart failure or clinically significant valvular disease, history of cardiac arrest, uncontrolled angina or arrhythmia, untreated serious conduction disorder (e.g., third-degree heart block), or acute myocardial ischemic condition suspected on the ECG at screening (e.g., ST-segment elevation, ST-segment depressions > 2 mm).
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 tablet | Drug | CK-2127107 1000 mg, then placebo, Placebo, then CK-212710 1000 mg |
| PlaceboOral tablet | Drug | CK-2127107 1000 mg, then placebo, Placebo, then CK-212710 1000 mg |
Primary outcome
Change From Period Baseline at Week 2 in Constant Work Rate (CWR) Endurance Time Relative to Placebo
Time frame: Baseline and week 2 of each treatment period
The CWR defines how long it takes until the participant reaches symptom limitations while simultaneously being monitored and is called "CWR time to intolerance," which determined the "CWR endurance time". Positive change indicates an improvement from baseline (i.e., a favorable outcome).
25 secondary outcomes
Change From Period Baseline at Week 2 in Oxygen Uptake (VO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilation (VE)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Inspiratory Capacity (IC) Change From Peak to Rest
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Perceived Exertion for Dyspnea and Leg Discomfort (BORG CR10)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Respiratory Exchange Ratio (RER)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Carbon Dioxide Output (VCO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in End-tidal PCO2 (PETCO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in End-tidal PO2 (PETO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Tidal Volume (VT)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Breathing Frequency (Bf)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Inspiratory Capacity (IC)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline to Week 2 in Inspiratory Reserve Volume (IRV)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Ventilatory Reserve (VE/MVV)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Heart Rate (HR)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Systolic Blood Pressure (SBP)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Diastolic Blood Pressure (DBP)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Arterial Oxygen Saturation From Pulse Oximetry (SpO2)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Forced Vital Capacity (FVC)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Forced Expiratory Volume 1 (FEV1)
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in FVC/FEV1 Ratio
Time frame: Baseline and week 2 of each treatment period
Change From Period Baseline at Week 2 in Activation of Accessory Respiratory Muscles
Time frame: Baseline and week 2 of each treatment period
Number of Participants With Treatment Emergent Adverse Events
Time frame: From first dose of study drug up to 14 days after last dose of study drug (8 weeks)
Plasma Concentration of CK-2127107 at Day 1 Predose, Day 14 Lowest Concentration (Ctrough), and Day 14 Concentration Predose 6 Hours (C6h)
Time frame: Day 1 predose, day 14 Ctrough, day 14 C6h
Plasma Concentration of CK-2127106 (Metabolite of CK-2127107) at Day 1 Predose, Day 14 Ctrough, Day 14 C6h
Time frame: Day 1 predose, day 14 Ctrough, day 14 C6h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reldesemtiv in people with Chronic Obstructive Pulmonary Disease (COPD), run by Astellas Pharma Global Development, Inc. at 2 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 17 inclusion and 27 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: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Week 2 in Constant Work Rate (CWR) Endurance Time Relative to Placebo (time frame: Baseline and week 2 of each treatment period). 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 14 Nov 2024.