Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | November 2012 |
End Date: | November 2013 |
Contact: | Amgen Call Center |
Phone: | 866-572-6436 |
An Open-label, Single-dose Study of the Safety, Tolerability, and Pharmacokinetics of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency and Effect of Hemodialysis on AMG 423 Pharmacokinetics
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.
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
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