Study Details

A study of ASP0367 in people with kidneys that do not work well and in healthy people

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT05117294

Astellas Study ID

The unique identification code given by the study sponsor.

0367-CL-1111

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2021-004042-38

Condition

Kidney Disease, Healthy Volunteer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - 75 Years

Sex

Female & Male

Product

ASP0367

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Dec 2021 - Nov 2022

Masking

None (Open Label)

Enrollment number

13

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

Study summary

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Locations

Advanced Pharma CR, LLC

Miami, United States, 33147

Nucleus Network

St Paul, United States, 55114

Inland Empire

Rialto, United States, 92377

Pinnacle Research Group

Anniston, United States, 36207