NCT01737866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

October 16, 2012

Last Update Submit

July 25, 2021

Conditions

Heart Failure

Keywords

Heart, Failure, Renal, Insufficiency, Cardiac, Kidney, Hemodialysis, Impairment, omecamtiv mecarbil, cardiac myosin activator, CK-1827452

Outcome Measures

Primary Outcomes (1)

  • AMG 423 Pharmacokinetic Parameters

    Part A and Part B: Total AMG 423 pharmacokinetic parameters including area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable sample (AUC0-t) and maximum observed plasma concentration after dosing (Cmax).

    Twenty time points, up to eight days

Secondary Outcomes (4)

  • Other Total AMG 423 PK Parameters

    Twenty time points, up to eight days

  • AMG 423 Dialysis Clearance

    Hours 4, 5, 6, 7 & 8 post-dose

  • AMG 423 Metabolites

    Twenty time points, up to eight days

  • Safety

    Up to 46 days, including a 28 day screening period

Study Arms (6)

Group 1

EXPERIMENTAL

End Stage Renal Diseas (ESRD) requiring hemodialysis

Drug: AMG 423

Group 2

EXPERIMENTAL

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

Drug: AMG 423

Group 3

EXPERIMENTAL

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

Drug: AMG 423

Group 4

EXPERIMENTAL

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

Drug: AMG 423

Group 5

EXPERIMENTAL

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

Drug: AMG 423

Group 6

EXPERIMENTAL

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

Drug: AMG 423

Interventions

AMG 423DRUG

omecamtiv mecarbil

Group 1Group 2Group 3Group 4Group 5Group 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Orlando, Florida, 32809, United States

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

November 30, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations

US(1)