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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05489614
Recruitment Status : Completed
First Posted : August 5, 2022
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: Olpasiran Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : September 13, 2022
Actual Primary Completion Date : October 24, 2023
Actual Study Completion Date : December 19, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Olpasiran
Participants will receive olpasiran by subcutaneous (SC) injection.
Other Name: AMG 890
Experimental: 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.
 Drug: Olpasiran
Participants will receive olpasiran by subcutaneous (SC) injection.
Other Name: AMG 890


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of Olpasiran [ Time Frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29 ]
  2. Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran [ Time Frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29 ]
  3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran [ Time Frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29 ]
  4. Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran [ Time Frame: 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 :
  1. Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a]) [ Time Frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85 ]
  2. Maximum Inhibitory Effect (Imax) of Plasma Lp(a) [ Time Frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85 ]
  3. Time to Reach Imax of Lp(a) [ Time Frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85 ]
  4. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to Day 85 ]
  5. Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations [ Time Frame: Up to Day 85 ]
  6. Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements [ Time Frame: Up to Day 85 ]
  7. Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: Up to Day 85 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489614


Locations
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United States, California
Inland Empire Clinical Trials, LLC
Rialto, California, United States, 92377-4697
CRSCA HC LLC, dba Creekside Post Acute
Yucaipa, California, United States, 92399
United States, Florida
Clinical Pharmacology Of Miami, LLC
Miami, Florida, United States, 33014
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147-4040
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
Nucleus Network - Minneapolis
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05489614    
Other Study ID Numbers: 20220010
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Olpasiran
Renal Impairment
Normal Renal Function
AMG 890
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases