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A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

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.
NCT05495581

Astellas Study ID

The unique identification code given by the study sponsor.

5354-CL-0004

EudraCT ID

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

N/A

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Condition

Healthy Volunteer, Kidney Disease

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

ASP5354

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

Aug 2022 - May 2023

Masking

None (Open Label)

Enrollment number

28

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 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

Orange County Research Center

Tustin, United States, 92780

Pinnacle Research Group

Anniston, United States, 36207

Sekino Clinical Pharmacology Clinic

Toshima-ku, Japan

P-One Clinic

Hachioji, Japan

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