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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01737866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
  • 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;
  • 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;
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Drug: AMG 423
omecamtiv mecarbil
Study Arms  ICMJE
  • Experimental: Group 1
    End Stage Renal Diseas (ESRD) requiring hemodialysis
    Intervention: Drug: AMG 423
  • Experimental: Group 2
    Normal renal function (eGFR >or = 80mL/min/1.73m^2)
    Intervention: Drug: AMG 423
  • Experimental: Group 3
    Mild decrease in GFR (eGFR 60-79 mL/min/1.73m^2)
    Intervention: Drug: AMG 423
  • Experimental: Group 4
    Moderate decrease in GFR (eGFR 30-59 mL/min/1.73m^2)
    Intervention: Drug: AMG 423
  • Experimental: Group 5
    Severe decrease in GFR (eGFR 15-29 mL/min/1.73m^2)
    Intervention: Drug: AMG 423
  • Experimental: Group 6
    Normal renal function (eGFR >or = 80mL/min/1.73m^2)
    Intervention: Drug: AMG 423
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2012)
36
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01737866
Other Study ID Numbers  ICMJE 20080676
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Cytokinetics
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP