NCT05117294

A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People

A Phase 1 Open Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP0367 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people. This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up. In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part. If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part. In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit. People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people's vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems.

Conditions

• Renal Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Bocidelpar	Oral

Timeline

• Start date: 2021-12-21
• Primary completion: 2022-11-13
• Completion: 2022-11-22
• First posted: 2021-11-11
• Last updated: 2024-10-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study