Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency

Completed · Phase 1

Conditions studied: Heart Failure

In brief

A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.

Key facts

Study ID

NCT01737866

Run by

Cytokinetics

People needed

13

Starts

2012-11-01

Expected to finish

2013-05-01

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or women ≥18 years of age
• Laboratory test values (clinical chemistry and hematology)within normal limits, (other than test values out of the normal range for subjects with CKD [groups 1 and 3 through 5]), or clinically acceptable to the investigator and sponsor at screening and day -3
• Free of any clinically significant disease or condition(s) (other than that consistent with CKD for subjects in groups 1 and 3 through 5) that require a physician's care and/or would interfere with the evaluations, procedures, or participation in the study per the investigator's discretion;

You may not qualify if…

• Subjects whose second MDRD eGFR result during the screening period is not within 10% of the first eGFR result
• Subjects who have received a functioning renal transplant within the past year
• Subjects with ESRD who do not have a functioning hemodialysis access
• Subjects with hemodynamic instability during hemodialysis
• Subjects whose renal insufficiency is due to active autoimmune renal disease
• Subjects with renal insufficiency or ESRD requiring hemodialysis and Troponin I > upper limit of normal (ULN) at screening or day -3
• Subjects with history of heart disease or unstable angina within the last 3 months
• Subjects with uncontrolled diabetes (Hb1Ac > 8%) and/or subjects who are able but unwilling to adhere to the required fasting intervals

Where it is running

• Research Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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