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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03626662




Registration number
NCT03626662
Ethics application status
Date submitted
19/06/2018
Date registered
13/08/2018

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Scientific 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)
Secondary ID [1] 0 0
20170544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 890
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Single Ascending Dose Cohorts

Experimental: AMG 890 - Single Ascending Dose Cohorts


Treatment: Drugs: AMG 890
Ascending Single Doses of AMG 890

Treatment: Drugs: Placebo
Calculated volume to match experimental drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of treatment-emergent adverse events
Timepoint [1] 0 0
up to 365 days
Primary outcome [2] 0 0
Changes in blood pressure
Timepoint [2] 0 0
Up to 365 days
Primary outcome [3] 0 0
Changes in heart rate
Timepoint [3] 0 0
Up to 365 days
Primary outcome [4] 0 0
Changes in respiratory rate
Timepoint [4] 0 0
Up to 365 days
Primary outcome [5] 0 0
Changes in temperature
Timepoint [5] 0 0
Up to 365 days
Primary outcome [6] 0 0
Changes in QRS interval
Timepoint [6] 0 0
Up to 365 days
Primary outcome [7] 0 0
Changes in PR interval
Timepoint [7] 0 0
Up to 365 days
Primary outcome [8] 0 0
Changes in QT interval
Timepoint [8] 0 0
Up to 365 days
Primary outcome [9] 0 0
Changes in RR interval
Timepoint [9] 0 0
Up to 365 days
Primary outcome [10] 0 0
Changes in red blood cells
Timepoint [10] 0 0
Up to 365 days
Primary outcome [11] 0 0
Changes in platelets
Timepoint [11] 0 0
Up to 365 days
Primary outcome [12] 0 0
Changes in white blood cells
Timepoint [12] 0 0
Up to 365 days
Primary outcome [13] 0 0
Changes in prothrombin time (PT)
Timepoint [13] 0 0
Up to 365 days
Primary outcome [14] 0 0
Changes in international normalized ratio (INR)
Timepoint [14] 0 0
Up to 365 days
Primary outcome [15] 0 0
Changes in activated partial thromboplastin time (aPTT)
Timepoint [15] 0 0
Up to 365 days
Primary outcome [16] 0 0
Changes in Thrombin time (TT)
Timepoint [16] 0 0
Up to 365 days
Primary outcome [17] 0 0
Changes in aspartate aminotransferase (AST) levels (units: U/L)
Timepoint [17] 0 0
Up to 365 days
Primary outcome [18] 0 0
Changes in alanine aminotransferase (ALT) levels (units: U/L)
Timepoint [18] 0 0
Up to 365 days
Primary outcome [19] 0 0
Changes in total bilirubin levels (units: µmol/L)
Timepoint [19] 0 0
Up to 365 days
Primary outcome [20] 0 0
Changes in direct bilirubin levels (units: µmol/L)
Timepoint [20] 0 0
Up to 365 days
Primary outcome [21] 0 0
Changes in alkaline phosphatase levels (units: U/L)
Timepoint [21] 0 0
Up to 365 days
Primary outcome [22] 0 0
Changes in total protein levels (units: g/L)
Timepoint [22] 0 0
Up to 365 days
Primary outcome [23] 0 0
Changes in albumin levels (units: g/L)
Timepoint [23] 0 0
Up to 365 days
Secondary outcome [1] 0 0
Pharmacokinetics parameter of maximum observed concentration (Cmax)
Timepoint [1] 0 0
up to 365 days
Secondary outcome [2] 0 0
Pharmacokinetics parameter of time of maximum observed concentration (tmax)
Timepoint [2] 0 0
up to 365 days
Secondary outcome [3] 0 0
Pharmacokinetics parameter of area under the concentration time curve (AUC)
Timepoint [3] 0 0
up to 365 days
Secondary outcome [4] 0 0
Change in plasma Lp(a) over time
Timepoint [4] 0 0
Up to 365 days
Secondary outcome [5] 0 0
Percent change in plasma Lp(a) over time
Timepoint [5] 0 0
Up to 365 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/04/2023
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Clinical Medical and Analytical eXellence CMAX - Adelaide
Recruitment hospital [2] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03626662