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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Olpasiran

• Registration Number: NCT05489614
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2022-09-13
• Primary Completion: 2023-10-24
• Study Completion: 2023-12-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose Olpasiran Renal Impairment	Olpasiran	Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1.
Single Dose Olpasiran Normal Renal Function	Olpasiran	Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration (Cmax) of Olpasiran	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	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	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	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

Name	Time	Method
Number of Participants with Clinically Significant Changes in Vital Signs	Up to Day 85
Time to Reach Imax of Lp(a)	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)	Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])	Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements	Up to Day 85
Number of Participants Who Experience an Adverse Event (AE)	Up to Day 85
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations	Up to Day 85

Trial Locations

Locations (6)

Inland Empire Clinical Trials, LLC; 🇺🇸 Rialto, California, United States

CRSCA HC LLC, dba Creekside Post Acute; 🇺🇸 Yucaipa, California, United States

Clinical Pharmacology Of Miami, LLC; 🇺🇸 Miami, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Nucleus Network - Minneapolis; 🇺🇸 Saint Paul, Minnesota, United States