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The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Olpasiran Hepatic Impairment | Experimental | Participants will be enrolled in 1 of 3 hepatic impairment groups based on their hepatic impairment status, as determined by Child-Pugh classification. All participants will receive a single dose of olpasiran on Day 1. |
|
| Single Dose Olpasiran Normal Hepatic Function | Experimental | Participants with normal hepatic function will be enrolled and will receive a single dose of olpasiran on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olpasiran | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Participants with Normal Hepatic Function Only:
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee).
Participants with Hepatic Impairment Only:
• Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings.
Exclusion Criteria:
Participants with Normal Hepatic Function Only:
Participants with Hepatic Impairment Only:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Clinical Trials, LLC | Rialto | California | 92377 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| 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 |
| 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 |
| Number of Participants With Clinically Significant Changes 12-lead Electrocardiogram (ECG) Measurements | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to Day 85 |
| Orlando |
| Florida |
| 32809 |
| United States |
| The Texas Liver Institute, Inc. | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| C000723009 | olpasiran |
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