Study Complete
Sponsor ID
20170544

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

Sponsor ID
20170544
Clinicaltrials.gov ID
NCT03626662
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
Olpasiran
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
79
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment-emergent adverse events

Timeframe: up to 365 days

Changes in blood pressure

Timeframe: Up to 365 days

Changes in heart rate

Timeframe: Up to 365 days

Changes in respiratory rate

Timeframe: Up to 365 days

Changes in temperature

Timeframe: Up to 365 days

Changes in QRS interval

Timeframe: Up to 365 days

Changes in PR interval

Timeframe: Up to 365 days

Changes in QT interval

Timeframe: Up to 365 days

Changes in RR interval

Timeframe: Up to 365 days

Changes in red blood cells

Timeframe: Up to 365 days

Changes in platelets

Timeframe: Up to 365 days

Changes in white blood cells

Timeframe: Up to 365 days

Changes in prothrombin time (PT)

Timeframe: Up to 365 days

Changes in international normalized ratio (INR)

Timeframe: Up to 365 days

Changes in activated partial thromboplastin time (aPTT)

Timeframe: Up to 365 days

Changes in Thrombin time (TT)

Timeframe: Up to 365 days

Changes in aspartate aminotransferase (AST) levels (units: U/L)

Timeframe: Up to 365 days

Changes in alanine aminotransferase (ALT) levels (units: U/L)

Timeframe: Up to 365 days

Changes in total bilirubin levels (units: μmol/L)

Timeframe: Up to 365 days

Changes in direct bilirubin levels (units: μmol/L)

Timeframe: Up to 365 days

Changes in alkaline phosphatase levels (units: U/L)

Timeframe: Up to 365 days

Changes in total protein levels (units: g/L)

Timeframe: Up to 365 days

Changes in albumin levels (units: g/L)

Timeframe: Up to 365 days

Secondary Outcome Measures

Pharmacokinetics parameter of maximum observed concentration (Cmax)

Timeframe: up to 365 days

Pharmacokinetics parameter of time of maximum observed concentration (tmax)

Timeframe: up to 365 days

Pharmacokinetics parameter of area under the concentration time curve (AUC)

Timeframe: up to 365 days

Change in plasma Lp(a) over time

Timeframe: Up to 365 days

Percent change in plasma Lp(a) over time

Timeframe: Up to 365 days

Locations

Location
Status
Contact Us
Location
Linear Clinical Research Limited
Nedlands, WA, Australia, 6009
Status
Recruiting
Location
QPS Miami Research Associates
South Miami, FL, United States, 33143
Status
Recruiting
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Recruiting
Location
Excel Medical Clinical Trials
Boca Raton, FL, United States, 33434
Status
Recruiting
Location
New York University
New York, NY, United States, 10016
Status
Recruiting
Location
Jacksonville Center for Clinical Research
Jacksonville, FL, United States, 32216
Status
Recruiting
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