A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

Exclusion Criteria

• •Participant has signs and/or symptoms due to a cerebellar, pyramidal, extrapyramidal or other nonmyopathic process (e.g., cerebellar dysfunctions, movement disorder) that would interfere in any nontrivial manner with aCPET or SHAPE Test.
• •Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• •Participant has any condition which makes the participant unsuitable for study participation.
• •Participant has used moderate or strong inducers of CYP3A, CYP2C8 and CYP2C19 within the 3 months prior to day -1.
• •Participant has cardiac troponin I (cTnI) \> ULN (or cardiac troponin T \> ULN if cTnI is not available) at screening.
• •Participant has estimated glomerular filtration rate (eGFR) calculated by the modification of diet in renal disease equation \< 60 mL/min per 1.73 m\^2 at screening.
• •Participant has at screening: total bilirubin (TBL) \> upper limit of normal (ULN) or transaminase(s) (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \> ULN in the absence of elevations in creatine kinase.
• •Participant has diabetes mellitus (types 1 or 2).
• •Participant has mental conditions such as schizophrenia, bipolar disorder or major depressive disorder that has not been under control within 1 year prior to screening.
• •Participant has severe behavioral or cognitive problems that preclude participation in the study.
• •Participant has a history of suicide attempt, suicidal behavior or has any suicidal ideation within 1 year prior to screening that meets criteria at a level of 4 or 5 by using the Columbia-Suicide Severity Rating Scale (C-SSRS) or who is at significant risk to commit suicide.
• •Participant has undergone an inpatient hospitalization within the 30 days prior to the randomization or has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments.
• •Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis, pulmonary fibrosis and lung cancers) and/or cardiac disease (medical history or current clinical findings) or prior interventional cardiac procedure (e.g., left heart catheterization which resulted in angioplasty/percutaneous coronary intervention, balloon valvuloplasty, etc.) within 3 months prior to randomization.
• •Participant has a pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device, or has a mean corrected QT interval using Fridericia's formula (QTcF) \> 450 msec for male participants and \> 470 msec for female participants at screening or randomization. If QTcF exceeds these limits, 1 additional triplicate ECG can be taken on the same day in order to determine the participant's eligibility.
• •Participant has ECG evidence of acute ischemia, atrial fibrillation or active conduction system abnormalities at screening, with the exception of any of the following:
• •* First degree atrioventricular (AV)-block
• •* Second degree AV-block type 1 (Mobitz type 1/Wenckebach type)
• •* Right bundle branch block
• •Participant has a seizure disorder that may interfere with their ability to complete all study requirements.
• •Participant has an active malignancy or any other cancer from which the participant has been disease-free for \< 5 years.
• •Participant has a solid organ transplant and is currently receiving treatment with therapy for immunosuppression.
• •Participant has a positive serology test for human immunodeficiency virus, hepatitis B or hepatitis C infection at screening.
• •Participant has previously received ASP0367.
• •Participant has a history of active substance abuse within 1 year prior to randomization.
• •Participant has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or on day -1.
• •Participant has a history of consuming \> 14 units for male participants or 7 units for female participants of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
• •Participant has used any drugs of abuse, that are not prescribed for a medical diagnosis (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse without a prescription (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1.
• •Participant has used any PPAR ligands such as fibrates and thiazolidinediones (e.g., clinofibrate, clofibrate, fenofibrate, gemfibrozil, pioglitazone, rosiglitazone) within 4 weeks prior to randomization.
• •Participant has used mestinon within 2 weeks prior to randomization.
• •Participant has initiated the use of coenzyme Q10 (CoQ10), carnitine, creatine or other mitochondrial-focused supplements within 4 weeks prior to randomization.
• •Participant has initiated an exercise regimen within 4 weeks prior to randomization.
• •Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
• •Participant has a positive result for SARS-CoV-2 polymerase chain reaction (PCR) test at screening.