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Bocidelpar for Reduced Maximum Oxygen Uptake Syndrome

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 7
Awards & highlights

Study Summary

This trial will study ASP0367, a potential new drug, to see if it is better than placebo at improving aerobic capacity, as well as safety and tolerability. It will also compare the drug to placebo in terms of other measures of aerobic capacity and functional capacity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiopulmonary Exercise Test
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
+3 more
Secondary outcome measures
Change from baseline in multivariable gas exchange index (MGI) during SHAPE Test.
Change from baseline in percent predicted VO2max during aCPET
Change from baseline in systemic oxygen extraction (SOE)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bocidelpar (ASP0367)Experimental Treatment1 Intervention
Participants will receive Bocidelpar (ASP0367) once daily in the morning for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo once daily in the morning for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bocidelpar
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,031 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
13,046 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Bocidelpar be detrimental to human health?

"As it is a Phase 1 trial, meaning minimal information exists on its efficacy and safety, the Bocidelpar scored a '1' for our team's risk assessment."

Answered by AI

Do I meet the prerequisites to join this experiment?

"This clinical trial is currently accepting 40 individuals aged 18-60 with diminished maximum oxygen uptake due to inadequate systemic oxygen extraction. Eligibility criteria include body mass index (BMI) between 17 and 36 kg/m^2, the ability to adhere to the study requirements for its duration, a peak exercise ([Ca-VO2])/[Hb] ≤ 0.85 and VO2max < 85% predicted in absence of cardiac or pulmonary limitation determined by cardiopulmonary exercize test (CPET), nonpregnant women who agree not to breastfeed during treatment period and 28 days following IP administration, male participants must"

Answered by AI

What are the paramount goals of this trial?

"The main goal of this trial, to be measured over a 6 week period, is to determine the safety and tolerability of the medication through Adverse Events (AEs). Secondary objectives include exploring how changes in workload at ventilatory anaerobic threshold (VAT) during aCPET, predicted V02max during aCPET, and workload at peak during aCPET will vary from baseline."

Answered by AI

Is this experiment still enrolling participants?

"Affirmative. Clinicaltrials.gov displays that this investigation, which was initially posted on May 27th 2021, is currently recruiting individuals for participation. This research requires 40 subjects from a single medical facility to complete the study."

Answered by AI

What is the aggregate number of individuals participating in this medical trial?

"Affirmative. The information on clinicialtrials.gov demonstrate that this clinical study, which was posted initially on May 27th 2021, is currently accepting participants. Approximately 40 individuals must be enrolled from 1 site."

Answered by AI

Are there any age restrictions for participation in this trial?

"This medical study is seeking participants who are aged 18 and above but younger than 60."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction
2021. "A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855201.
~8 spots leftby Apr 2025
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