Study Details

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in subjects with renal impairment and in Type 2 Diabetes Mellitus Subjects with Chronic Kidney Disease

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.
NCT02218099

Astellas Study ID

The unique identification code given by the study sponsor.

8232-CL-0002

EudraCT ID

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

2013-000680-89

Condition

Healthy Volunteer, Other, Kidney Disease, Adult Onset Diabetes

Phase

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

Phase 1

Age

35 years - 80 years

Sex

Female & Male

Product

N/A

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

Sep 2013 - Sep 2014

Masking

Triple (Participant, Care Provider, Investigator)

Enrollment number

55

A Phase 1 Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 (Part 1) and a Multiple Dose, Placebo-controlled Exploratory Safety, Pharmacokinetic and Pharmacodynamic Study in Type 2 Diabetes Mellitus Subjects with Chronic Kidney Disease (Part 2)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site: 37301

Chisinau, Republic of Moldova

Site: 35901

Sofia, Bulgaria, 1612

Site: 40001

Bucharest, Romania, 10731