Study Complete
Sponsor ID
20220009

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants with Various Degrees of Hepatic Impairment

Sponsor ID
20220009
Clinicaltrials.gov ID
NCT05481411
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.

Additional Study Details

Phase
Phase 1
Product
Olpasiran
Type
Interventional
Masking
None (Open Label)
Enrollment
25
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of Olpasiran

Timeframe: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran

Timeframe: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran

Timeframe: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

Secondary Outcome Measures

Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])

Timeframe: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

Maximum Inhibitory Effect (Imax) of Plasma Lp(a)

Timeframe: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

Time to Reach Imax of Lp(a)

Timeframe: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

Number of Participants Who Experience an Adverse Event (AE)

Timeframe: Up to Day 85

Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations

Timeframe: Up to Day 85

Number of Participants With Clinically Significant Changes 12-lead Electrocardiogram (ECG) Measurements

Timeframe: Up to Day 85

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to Day 85

Locations

Location
Status
Contact Us
Location
Orlando Clinical Research Center
Orlando, FL, United States, 32809
Status
Recruiting
Location
Inland Empire Clinical Trials, LLC
Rialto, CA, United States, 92377
Status
Recruiting
Location
The Texas Liver Institute, Inc.
San Antonio, TX, United States, 78215
Status
Recruiting