TerminatedPhase 1

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

Stopped: Lack of Pharmacological effect

United States31 participantsStarted 2021-06-14

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant agrees and is able to adhere to the study requirements for the length of the study, including undergoing both aCPET and SHAPE Test. * Participant has a body mass index (BMI) range of 17.0 to 36 kg/m\^2, inclusive and weighs at least 50 kg (male participant) or 40 kg (female participant) at screening. * Participants with reduced maximum oxygen uptake due to poor SOE, defined as peak exercise (\[Ca-VO2\])/\[Hb\]) ≤ 0.85 and VO2max \< 85% predicted in the absence of a cardiac or pulmonary mechanical limit, determined by aCPET within 6 months prior to day 1 or participants with reduced maximum oxygen uptake due to poor SOE, defined as peak exercise (\[Ca-VO2\])/\[Hb\]) ≤ 0.85 and VO2max \< 85% predicted in the absence of a cardiac or pulmonary mechanical limit, determined by historical aCPET within 45 months of screening and confirmed reduction in skeletal muscle citrate synthase activity. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP) * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after final IP administration. * Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration. * Female participant must not donate ova starting at first dose of IP and throughout the study period and for 28 days after final…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in maximum oxygen uptake at peak exercise (VO2max) during Advanced Cardiopulmonary Exercise Test (aCPET)

Timeframe: Baseline and Week 6

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Baseline up to week 7

Trial details

NCT IDNCT04855201

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-16

View on ClinicalTrials.gov More Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in maximum oxygen uptake at peak exercise (VO2max) during Advanced Cardiopulmonary Exercise Test (aCPET)

Timeframe: Baseline and Week 6

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)

Timeframe: Baseline up to week 7

Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Baseline up to week 7