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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

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: NCT03626662
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: AMG 890 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The subjects and the investigative site staff, except for the unblinded pharmacist, will be blinded to treatment assignment.
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : November 27, 2021
Estimated Study Completion Date : November 27, 2021

Arm Intervention/treatment
Placebo Comparator: Placebo
Single Ascending Dose Cohorts
Drug: Placebo
Calculated volume to match experimental drug.

Experimental: AMG 890
Single Ascending Dose Cohorts
Drug: AMG 890
Ascending Single Doses of AMG 890




Primary Outcome Measures :
  1. Subject incidence of treatment-emergent adverse events [ Time Frame: up to 365 days ]
  2. Changes in blood pressure [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group.

  3. Changes in heart rate [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  4. Changes in respiratory rate [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group.

  5. Changes in temperature [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group.

  6. Changes in QRS interval [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group.

  7. Changes in PR interval [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  8. Changes in QT interval [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group.

  9. Changes in RR interval [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  10. Changes in red blood cells [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  11. Changes in platelets [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  12. Changes in white blood cells [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  13. Changes in prothrombin time (PT) [ Time Frame: Up to 365 days ]
  14. Changes in international normalized ratio (INR) [ Time Frame: Up to 365 days ]
  15. Changes in activated partial thromboplastin time (aPTT) [ Time Frame: Up to 365 days ]
  16. Changes in Thrombin time (TT) [ Time Frame: Up to 365 days ]
  17. Changes in aspartate aminotransferase (AST) levels (units: U/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  18. Changes in alanine aminotransferase (ALT) levels (units: U/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  19. Changes in total bilirubin levels (units: μmol/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  20. Changes in direct bilirubin levels (units: μmol/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  21. Changes in alkaline phosphatase levels (units: U/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  22. Changes in total protein levels (units: g/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group

  23. Changes in albumin levels (units: g/L) [ Time Frame: Up to 365 days ]
    The analysis will include summary statistics at selected time points by treatment group


Secondary Outcome Measures :
  1. Pharmacokinetics parameter of maximum observed concentration (Cmax) [ Time Frame: up to 365 days ]
  2. Pharmacokinetics parameter of time of maximum observed concentration (tmax) [ Time Frame: up to 365 days ]
  3. Pharmacokinetics parameter of area under the concentration time curve (AUC) [ Time Frame: up to 365 days ]
  4. Change in plasma Lp(a) over time [ Time Frame: Up to 365 days ]
  5. Percent change in plasma Lp(a) over time [ Time Frame: Up to 365 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women with ages between 18 and 65 years old, inclusive.
  • Protocol-defined elevated plasma Lp(a) level.
  • Body mass index (BMI) greater than or equal to 18 and less than or equal to 32 kg/m2, at screening.
  • Women must be of non-reproductive potential.
  • Other Inclusion criteria may apply

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study.
  • Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
  • History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • History or clinical evidence of bleeding diathesis or any coagulation disorder.
  • History or clinical evidence of peripheral neuropathy.
  • Other Exclusion criteria may apply

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): NCT03626662


Locations
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United States, California
Research Site
Tustin, California, United States, 92780
United States, Florida
Research Site
Boca Raton, Florida, United States, 33434
Research Site
Jacksonville, Florida, United States, 32216
Research Site
South Miami, Florida, United States, 33143
United States, Kansas
Research Site
Kansas City, Kansas, United States, 66160
United States, New York
Research Site
New York, New York, United States, 10016
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45227
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia, 6009
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: NCT03626662    
Other Study ID Numbers: 20170544
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases