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

Cardiovascular Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626662
• Other study ID #: 20170544
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2018
• Est. completion date: April 18, 2023

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• AMG 890
Ascending Single Doses of AMG 890
• Placebo
Calculated volume to match experimental drug.

Locations

Country	Name	City	State
Australia	Clinical Medical and Analytical eXellence CMAX	Adelaide	South Australia
Australia	Linear Clinical Research Limited	Nedlands	Western Australia
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Medpace Inc	Cincinnati	Ohio
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	New York University	New York	New York
United States	QPS Miami Research Associates	South Miami	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Koren MJ, Moriarty PM, Baum SJ, Neutel J, Hernandez-Illas M, Weintraub HS, Florio M, Kassahun H, Melquist S, Varrieur T, Haldar SM, Sohn W, Wang H, Elliott-Davey M, Rock BM, Pei T, Homann O, Hellawell J, Watts GF. Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a). Nat Med. 2022 Jan;28(1):96-103. doi: 10.1038/s41591-021-01634-w. Epub 2022 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of treatment-emergent adverse events		up to 365 days
Primary	Changes in blood pressure	The analysis will include summary statistics at selected time points by treatment group.	Up to 365 days
Primary	Changes in heart rate	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in respiratory rate	The analysis will include summary statistics at selected time points by treatment group.	Up to 365 days
Primary	Changes in temperature	The analysis will include summary statistics at selected time points by treatment group.	Up to 365 days
Primary	Changes in QRS interval	The analysis will include summary statistics at selected time points by treatment group.	Up to 365 days
Primary	Changes in PR interval	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in QT interval	The analysis will include summary statistics at selected time points by treatment group.	Up to 365 days
Primary	Changes in RR interval	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in red blood cells	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in platelets	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in white blood cells	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in prothrombin time (PT)		Up to 365 days
Primary	Changes in international normalized ratio (INR)		Up to 365 days
Primary	Changes in activated partial thromboplastin time (aPTT)		Up to 365 days
Primary	Changes in Thrombin time (TT)		Up to 365 days
Primary	Changes in aspartate aminotransferase (AST) levels (units: U/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in alanine aminotransferase (ALT) levels (units: U/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in total bilirubin levels (units: µmol/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in direct bilirubin levels (units: µmol/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in alkaline phosphatase levels (units: U/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in total protein levels (units: g/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Primary	Changes in albumin levels (units: g/L)	The analysis will include summary statistics at selected time points by treatment group	Up to 365 days
Secondary	Pharmacokinetics parameter of maximum observed concentration (Cmax)		up to 365 days
Secondary	Pharmacokinetics parameter of time of maximum observed concentration (tmax)		up to 365 days
Secondary	Pharmacokinetics parameter of area under the concentration time curve (AUC)		up to 365 days
Secondary	Change in plasma Lp(a) over time		Up to 365 days
Secondary	Percent change in plasma Lp(a) over time		Up to 365 days

External Links

•   AmgenTrials clinical trials website