NCT04855201

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

A Phase 1b Multiple Oral Dose Study to Evaluate the Pharmacological Effect, Safety and Tolerability of ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

Interventions

Type	Name	Description
DRUG	Bocidelpar	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2021-06-14
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2021-04-22
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study