Study Complete
Sponsor ID
20190095
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants with Elevated Serum Lipoprotein(a)
Study Details
The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]).
Protocol Summary
Primary Outcome Measures
Maximum Observed Concentration (Cmax) of Olpasiran
Timeframe: Day 1 to Day 85
Area Under the Concentration-time Curve (AUC) of Olpasiran
Timeframe: Day 1 to Day 85
Time to Maximum Observed Concentration (tmax)
Timeframe: Day 1 to Day 85
Half-life (t1/2) of Olpasiran
Timeframe: Day 1 to Day 85
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
Timeframe: Day 1 to Day 85
Apparent Total Body Clearance (CL/F) of Olpasiran
Timeframe: Day 1 to Day 85
Secondary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Day 1 to Day 225
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Day 1 to Day 225
Number of Participants with a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Timeframe: Day 1 to Day 225
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Timeframe: Day 1 to Day 225
Number of Participants with a Clinically Siginificant Change from Baseline in Lipid Levels
Timeframe: Day 1 to Day 225
Number of Participants with a Clinically Significant Change from Baseline in Serum Lipoprotein(a) (LP[a])
Timeframe: Day 1 to Day 225
Locations
Location
Queen Mary Hospital
Hong Kong, HK, Hong Kong
Status
Recruiting