Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
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ClinicalTrials.gov Identifier: NCT03626662 |
Recruitment Status :
Completed
First Posted : August 13, 2018
Last Update Posted : October 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease | Drug: AMG 890 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 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 |
Actual Primary Completion Date : | April 18, 2023 |
Actual Study Completion Date : | April 18, 2023 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Single Ascending Dose Cohorts
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Drug: Placebo
Calculated volume to match experimental drug. |
Experimental: AMG 890
Single Ascending Dose Cohorts
|
Drug: AMG 890
Ascending Single Doses of AMG 890 |
- Subject incidence of treatment-emergent adverse events [ Time Frame: up to 365 days ]
- Changes in blood pressure [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group.
- Changes in heart rate [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in respiratory rate [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group.
- Changes in temperature [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group.
- Changes in QRS interval [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group.
- Changes in PR interval [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in QT interval [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group.
- Changes in RR interval [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in red blood cells [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in platelets [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in white blood cells [ Time Frame: Up to 365 days ]The analysis will include summary statistics at selected time points by treatment group
- Changes in prothrombin time (PT) [ Time Frame: Up to 365 days ]
- Changes in international normalized ratio (INR) [ Time Frame: Up to 365 days ]
- Changes in activated partial thromboplastin time (aPTT) [ Time Frame: Up to 365 days ]
- Changes in Thrombin time (TT) [ Time Frame: Up to 365 days ]
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Pharmacokinetics parameter of maximum observed concentration (Cmax) [ Time Frame: up to 365 days ]
- Pharmacokinetics parameter of time of maximum observed concentration (tmax) [ Time Frame: up to 365 days ]
- Pharmacokinetics parameter of area under the concentration time curve (AUC) [ Time Frame: up to 365 days ]
- Change in plasma Lp(a) over time [ Time Frame: Up to 365 days ]
- Percent change in plasma Lp(a) over time [ Time Frame: Up to 365 days ]
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.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Men and women with ages between 18 and 70 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 40 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
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
United States, California | |
Orange County Research Center | |
Tustin, California, United States, 92780 | |
United States, Florida | |
Excel Medical Clinical Trials | |
Boca Raton, Florida, United States, 33434 | |
Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
QPS Miami Research Associates | |
South Miami, Florida, United States, 33143 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
New York University | |
New York, New York, United States, 10016 | |
United States, Ohio | |
Medpace Inc | |
Cincinnati, Ohio, United States, 45227 | |
Australia, South Australia | |
Clinical Medical and Analytical eXellence CMAX | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Western Australia | |
Linear Clinical Research Limited | |
Nedlands, Western Australia, Australia, 6009 |
Study Director: | MD | Amgen |
Publications:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT03626662 |
Other Study ID Numbers: |
20170544 |
First Posted: | August 13, 2018 Key Record Dates |
Last Update Posted: | October 18, 2023 |
Last Verified: | October 2023 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiovascular Diseases |