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Safety Study of Omecamtiv Mecarbil in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT02601001
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE November 10, 2015
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Pharmacokinetics (Cmax) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    Cmax of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
  • Incidence of Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 35 days ]
    1. Subject incidence of adverse events 2. Changes from baseline in laboratory values and vital signs 3. Changes from baseline in electrocardiogram (ECG)
  • Pharmacokinetics (AUC) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    AUC12h of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
  • Pharmacokinetics (Tmax) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    Tmax of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
  • Pharmacokinetics [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    Cmax of omecamtiv mecarbil following dose administration.
  • Incidence of Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 35 days ]
    1. Subject incidence of adverse events 2. Changes from baseline in laboratory values and vital signs 3. Changes from baseline in electrocardiogram (ECG)
  • Pharmacokientics [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    AUC12h of omecamtiv mecarbil following dose administration.
  • Pharmacokinetics [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]
    Tmax of omecamtiv mecarbil following dose administration.
Change History Complete list of historical versions of study NCT02601001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Omecamtiv Mecarbil in Healthy Japanese Subjects
Official Title  ICMJE A Phase 1, Single Center Double-blind, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Omecamtiv Mecarbil in Healthy Japanese Subjects
Brief Summary The purpose of this study is to evaluate the PK, safety and tolerability of omecamtiv mecarbil in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: AMG 423
    Omecamtiv mecarbil at 25 mg and 37.5 mg
  • Drug: AMG 423
    Omecamtiv mercabil at 25 mg and 50 mg
  • Drug: Placebo
    Placebo Comparator
Study Arms  ICMJE
  • Placebo Comparator: Treatment group C
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Treatment group A
    25 mg and 37.5 mg
    Intervention: Drug: AMG 423
  • Active Comparator: Treatment group B
    25 mg and 50 mg
    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: November 6, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No history or evidence of clinically relevant medical disorders as determined by the Investigator, and in good health as determined by a pre-study physical examination and medical history with no clinically significant abnormalities, normal vital signs and no history or presence of a clinically significant abnormal electrocardiogram finding
  • Subjects' pre-study clinical laboratory findings (including creatine phosphokinase) should be within normal range or if outside of the normal range, are deemed not clinically significant by the Investigator

Exclusion Criteria:

  • A clinically significant disorder/disease, including gastro intestinal abnormalities that might interfere with absorption
  • An unstable medical condition, defined as having been hospitalized within 28 days before day 1, major surgery within 6 months before day 1, or otherwise unstable in the judgment of the Investigator
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
  • History of malignancy of any type other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before the day of dosing
  • Use of any prescription or over-the-counter medications within 14 days or 5 half-lives (whichever time period is greater), prior to receiving the first dose of omecamtiv mecarbil (Acetaminophen up to 2 grams per day for analgesia and hormone replacement therapy (e.g., estrogen) will be allowed
  • Use of any known inhibitors of CYP3A4/p-glycoprotein (P-gp) or CYP2D6 within 14 days or 5 half-lives, whichever is longer; or use of grapefruit juice or grapefruit containing products within 7 days prior to receiving the first dose of omecamtiv mecarbil
  • Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer, before receiving omecamtiv mecarbil
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02601001
Other Study ID Numbers  ICMJE 20150134
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 Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date January 2016

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