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)

Sponsor ID
20190095
Clinicaltrials.gov ID
NCT04987320
EUCTIS ID
N/A
EudraCT ID
N/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]).

Additional Study Details

Phase
Phase 1
Product
AMG 890
Type
Interventional
Masking
None (Open Label)
Enrollment
24
Additional Study Details

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
Status
Contact Us
Location
Queen Mary Hospital
Hong Kong, HK, Hong Kong
Status
Recruiting