The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo. This study will also evaluate the effect of ASP0367 on improvement of other aerobic capacity parameters relative to placebo, as well as evaluate the effect of ASP0367 on improvement of functional capacity relative to placebo.
The study will consist of a screening period (up to 27 days \[approximately 4 weeks\]), treatment period (up to 44 days \[6 weeks\]) and follow-up period (7 days \[1 week\]). The study will be completed with an end-of-study visit (ESV). The ESV will take place 7 days (1 week) after the end-of-treatment on day 44 (week 6) or 7 days (1 week) after early discontinuation from the study. The anticipated total duration of the study for each participant, including screening and follow-up, is approximately 75 days (11 week). An interim analysis may be performed before the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Oral
Oral
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change from baseline in maximum oxygen uptake at peak exercise (VO2max) during Advanced Cardiopulmonary Exercise Test (aCPET)
V02max is defined as maximum amount of oxygen body can utilize during exercise.
Time frame: Baseline and Week 6
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Adverse Events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
Time frame: Baseline up to week 7
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Baseline up to week 7
Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant vital signs values.
Time frame: Baseline up to week 7
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant 12-ECG values.
Time frame: Baseline up to week 7
Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 6 items for suicidal behavior (1. Actual attempt, 2. Interrupted attempt, 3. Aborted attempt, 4. Preparatory acts or behavior, 5. Suicidal Behavior 6. Completed suicide,) will be reported.
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Time frame: Baseline up to week 7
Change from baseline in systemic oxygen extraction (SOE)
Systemic oxygen extraction is defined as the difference between the arterial and venous concentrations of oxygen.
Time frame: Baseline and Week 6
Change from baseline in percent predicted VO2max during aCPET
Predicted V02max is measured by the maximum oxygen uptake at peak exercise.
Time frame: Baseline and Week 6
Change from baseline in workload at peak during aCPET
Change from baseline in workload at peak during aCPET
Time frame: Baseline and Week 6
Change from baseline in workload at ventilatory anaerobic threshold (VAT) during aCPET
Change from baseline in workload at ventilatory anaerobic threshold (VAT) during aCPET
Time frame: Baseline and Week 6
Change from baseline in multivariable gas exchange index (MGI) during SHAPE Test.
Change from baseline in multivariable gas exchange index (MGI) during SHAPE Test. The SHAPE Test is a noninvasive exercise test of the functional status of participants.
Time frame: Baseline and Week 6