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NCT04855201 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Astellas Pharma Global Development.

Terminated
Registry status
Phase 1
Development phase
31
Enrollment target

NCT04855201: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.

NCT04855201 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04855201, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.

TERMINATED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study 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.

Primary Outcome

V02max is defined as maximum amount of oxygen body can utilize during exercise.

Interventions

  • DRUG Placebo
  • DRUG Bocidelpar

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2021-06-14
Est. Completion 2022-12-16
Phase Phase 1
Astellas Pharma Global Development

168 total trials

Why NCT04855201 stopped before completion

NCT04855201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04855201 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04855201 about?

NCT04855201 is a clinical study titled "A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction". 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 param...

What is the current status of trial NCT04855201?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-06-14. Estimated completion is 2022-12-16.

What interventions are being tested in trial NCT04855201?

The interventions under investigation include: Placebo (DRUG), Bocidelpar (DRUG).

Who is sponsoring clinical trial NCT04855201?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04855201's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04855201, the US trial registry maintained by the National Library of Medicine. NCT04855201 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.