NCT05489614

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

A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Subjects With Normal Renal Function and Subjects With Various Degrees of Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Olpasiran	Participants will receive olpasiran by subcutaneous (SC) injection.

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-10-24
• Completion: 2023-12-19
• First posted: 2022-08-05
• Last updated: 2025-11-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study