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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single Dose Olpasiran Renal Impairment

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.

Group Type EXPERIMENTAL

Olpasiran

Intervention Type DRUG

Participants will receive olpasiran by subcutaneous (SC) injection.

Single Dose Olpasiran Normal Renal Function

Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.

Group Type EXPERIMENTAL

Olpasiran

Intervention Type DRUG

Participants will receive olpasiran by subcutaneous (SC) injection.

Interventions

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Olpasiran

Participants will receive olpasiran by subcutaneous (SC) injection.

Intervention Type DRUG

Other Intervention Names

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AMG 890

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes