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

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ClinicalTrials.gov Identifier: NCT01737866
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : August 13, 2013
Sponsor:
Collaborator:
Cytokinetics
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: AMG 423 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Group 1
End Stage Renal Diseas (ESRD) requiring hemodialysis
Drug: AMG 423
omecamtiv mecarbil

Experimental: Group 2
Normal renal function (eGFR >or = 80mL/min/1.73m^2)
Drug: AMG 423
omecamtiv mecarbil

Experimental: Group 3
Mild decrease in GFR (eGFR 60-79 mL/min/1.73m^2)
Drug: AMG 423
omecamtiv mecarbil

Experimental: Group 4
Moderate decrease in GFR (eGFR 30-59 mL/min/1.73m^2)
Drug: AMG 423
omecamtiv mecarbil

Experimental: Group 5
Severe decrease in GFR (eGFR 15-29 mL/min/1.73m^2)
Drug: AMG 423
omecamtiv mecarbil

Experimental: Group 6
Normal renal function (eGFR >or = 80mL/min/1.73m^2)
Drug: AMG 423
omecamtiv mecarbil




Primary Outcome Measures :
  1. AMG 423 Pharmacokinetic Parameters [ Time Frame: Twenty time points, up to eight days ]
    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).


Secondary Outcome Measures :
  1. Other Total AMG 423 PK Parameters [ Time Frame: Twenty time points, up to eight days ]
    Total AMG 423 pharmacokinetic parameters including but not limited to terminal phase half life (t1/2) and time of maximum AMG 423 plasma concentration (tmax), AUC from time 0 to infinity (AUCinf) and apparent plasma clearance (CL/F) for Part A and Part B;

  2. AMG 423 Dialysis Clearance [ Time Frame: Hours 4, 5, 6, 7 & 8 post-dose ]
    AMG 423 dialysis clearance (CLd) for ESRD subjects in Part A;

  3. AMG 423 Metabolites [ Time Frame: Twenty time points, up to eight days ]
    AMG 423 metabolites (M3 and M4) pharmacokinetic parameters including but not limited to AUC0-t, AUCinf, AUC metabolite to parent ratios, Cmax, tmax and t1/2, if appropriate.

  4. Safety [ Time Frame: Up to 46 days, including a 28 day screening period ]
    Secondary safety endpoints are subject incidence of adverse events and clinically significant changes in vital signs, physical examinations, clinical laboratory tests and ECGs.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737866


Locations
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United States, Florida
Research Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Amgen
Cytokinetics
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01737866     History of Changes
Other Study ID Numbers: 20080676
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013
Keywords provided by Amgen:
Heart, Failure, Renal, Insufficiency, Cardiac, Kidney, Hemodialysis, Impairment, omecamtiv mecarbil, cardiac myosin activator, CK-1827452
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases