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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

End Stage Renal Diseas (ESRD) requiring hemodialysis

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Group 2

Normal renal function (eGFR \>or = 80mL/min/1.73m\^2)

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Group 3

Mild decrease in GFR (eGFR 60-79 mL/min/1.73m\^2)

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Group 4

Moderate decrease in GFR (eGFR 30-59 mL/min/1.73m\^2)

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Group 5

Severe decrease in GFR (eGFR 15-29 mL/min/1.73m\^2)

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Group 6

Normal renal function (eGFR \>or = 80mL/min/1.73m\^2)

Group Type EXPERIMENTAL

AMG 423

Intervention Type DRUG

omecamtiv mecarbil

Interventions

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AMG 423

omecamtiv mecarbil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes