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

• Status: Not yet recruiting
• Trial end date: 2023-08-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

Inclusion:

• Male participants or female participants of nonchildbearing potential between 18 and 75 years of age (inclusive) at the time of Screening.

• Body mass index between 18 and 40 kg/m^2 (inclusive) at the time of Screening.

• Eligible participants classified based on established need for renal replacement therapy and eGFR at Screening. Assignment will be based on eGFR at Screening.

1. Group 1 (Normal): eGFR ≥ 90 mL/min and no history of renal disease.

2. Group 2 (Mild): 60 ≤ eGFR ≤ 89 mL/min.

3. Group 3 (Moderate): 30 ≤ eGFR ≤ 59 mL/min.

4. Group 4 (Severe): 15 ≤ eGFR ≤ 29 mL/min without dialysis.

5. Group 5 (Kidney Failure): eGFR < 15 mL/min and dialysis patients (off-dialysis).

6. Group 6 (Kidney Failure): eGFR < 15 mL/min and dialysis patients (on-dialysis).

Exclusion:

• Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal.

• Clinically significant hyperkalemia (defined by serum potassium concentration as > 5.5 mEq/L for Groups 1 to 4, > 6 mEq/L for Groups 5 and 6) at Screening or Check-in.

• History of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.

• Female participants with a positive pregnancy test at Screening or Check-in.

• Participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to Check-in.

Participants in Group 1 only (participants with normal renal function) are excluded if:

• A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at Screening or Check-in.

Participants in Groups 2 to 6 (participants with varying degrees of renal impairment) are excluded if:

• A change in disease status within 30 days of Screening, as documented by the participant's medical history, deemed clinically significant by the Investigator.