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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Olpasiran Renal Impairment | Experimental | 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. |
|
| Single Dose Olpasiran Normal Renal Function | Experimental | Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olpasiran | Drug | Participants will receive olpasiran by subcutaneous (SC) 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 | |
| Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran | Pre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4 |
| 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:
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.
Exclusion:
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.
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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 | 92377-4697 | United States | ||
| CRSCA HC LLC, dba Creekside Post Acute |
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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 in 12-lead Electrocardiogram (ECG) Measurements | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to Day 85 |
| Yucaipa |
| California |
| 92399 |
| United States |
| Clinical Pharmacology Of Miami, LLC | Miami | Florida | 33014 | United States |
| Advanced Pharma CR, LLC | Miami | Florida | 33147-4040 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Nucleus Network - Minneapolis | Saint Paul | Minnesota | 55114 | United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000723009 | olpasiran |
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