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Trial record 11 of 13 for:    “omecamtiv mecarbil or CK-1827452 and heart failure”

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

Brief Summary:
The purpose of this study is to evaluate the PK, safety and tolerability of omecamtiv mecarbil in healthy volunteers.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Single Center Double-blind, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Omecamtiv Mecarbil in Healthy Japanese Subjects
Study Start Date : November 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Placebo Comparator: Treatment group C
Placebo
Drug: Placebo
Placebo Comparator

Active Comparator: Treatment group A
25 mg and 37.5 mg
Drug: AMG 423
Omecamtiv mecarbil at 25 mg and 37.5 mg

Active Comparator: Treatment group B
25 mg and 50 mg
Drug: AMG 423
Omecamtiv mercabil at 25 mg and 50 mg




Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02601001


Locations
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Japan
Research Site
Kagoshima-shi, Kagoshima, Japan, 890-0081
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02601001     History of Changes
Other Study ID Numbers: 20150134
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases