A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease

Inclusion Criteria

• 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 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.
• Subject has known active tuberculosis.
• Subject has undergone thoracotomy with pulmonary resection (except for sub-lobar resection).
• Subject has resting pulse 100 bpm; resting systolic blood pressure > 160 mm Hg or 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.