Study Complete
Sponsor ID
20220010

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

Sponsor ID
20220010
Clinicaltrials.gov ID
NCT05489614
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.

Additional Study Details

Phase
Phase 1
Product
Olpasiran
Type
Interventional
Masking
None (Open Label)
Enrollment
33
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

Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran

Timeframe: Pre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4

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 in 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, 92377-4697
Status
Recruiting
Location
Nucleus Network - Minneapolis
St. Paul, MN, United States, 55114
Status
Recruiting
Location
Clinical Pharmacology Of Miami, LLC
MIAMI, FL, United States, 33014
Status
Recruiting
Location
CRSCA HC LLC, dba Creekside Post Acute
Yucaipa, CA, United States, 92399
Status
Recruiting
Location
Advanced Pharma CR, LLC
Miami, FL, United States, 33147-4040
Status
Recruiting