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

Amgen79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Cardiovascular Disease

Interventions

AMG 890DRUG

Ascending Single Doses of AMG 890

PlaceboDRUG

Calculated volume to match experimental drug.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

Orange County Research Center

Tustin, California, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.

Time frame: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months

Secondary Outcomes

Maximum Observed Concentration (Cmax) of Olpasiran

Blood samples were collected for measurement of serum concentrations of Olpasiran.

Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose

Time to Reach Cmax (Tmax) of Olpasiran

Blood samples were collected for measurement of serum concentrations of Olpasiran.

Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran

Blood samples were collected for measurement of serum concentrations of Olpasiran.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.