Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
- Registration Number
- NCT03626662
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Single Ascending Dose Cohorts AMG 890 AMG 890 Single Ascending Dose Cohorts
- Primary Outcome Measures
Name Time Method Changes in respiratory rate Up to 365 days The analysis will include summary statistics at selected time points by treatment group.
Changes in temperature Up to 365 days The analysis will include summary statistics at selected time points by treatment group.
Changes in red blood cells Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in prothrombin time (PT) Up to 365 days Changes in activated partial thromboplastin time (aPTT) Up to 365 days Changes in Thrombin time (TT) Up to 365 days Changes in QRS interval 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) 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) Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in albumin levels (units: g/L) Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in RR interval Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in white blood cells Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Subject incidence of treatment-emergent adverse events up to 365 days Changes in blood pressure Up to 365 days The analysis will include summary statistics at selected time points by treatment group.
Changes in heart rate Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in PR interval Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in international normalized ratio (INR) Up to 365 days Changes in aspartate aminotransferase (AST) levels (units: U/L) 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) Up to 365 days The analysis will include summary statistics at selected time points by treatment group
Changes in QT interval Up to 365 days The analysis will include summary statistics at selected time points by treatment group.
Changes in platelets 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) 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) Up to 365 days The analysis will include summary statistics at selected time points by treatment group
- Secondary Outcome Measures
Name Time Method Change in plasma Lp(a) over time Up to 365 days Pharmacokinetics parameter of area under the concentration time curve (AUC) up to 365 days Percent change in plasma Lp(a) over time Up to 365 days Pharmacokinetics parameter of maximum observed concentration (Cmax) up to 365 days Pharmacokinetics parameter of time of maximum observed concentration (tmax) up to 365 days
Trial Locations
- Locations (9)
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
New York University
🇺🇸New York, New York, United States
QPS Miami Research Associates
🇺🇸South Miami, Florida, United States
Linear Clinical Research Limited
🇦🇺Nedlands, Western Australia, Australia
Orange County Research Center
🇺🇸Tustin, California, United States
Clinical Medical and Analytical eXellence CMAX
🇦🇺Adelaide, South Australia, Australia
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Medpace Inc
🇺🇸Cincinnati, Ohio, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States