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The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab Drug Substance A | Experimental | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
|
| Evolocumab Drug Substance B | Experimental | Participants will receive a single SC dose of evolocumab drug substance B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab Drug Substance A | Drug | Evolocumab drug substance A will be administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab | Day 1 to Day 64 | |
| Area Under the Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab | Day 1 to Day 64 | |
| Maximum Observed Concentration (Cmax) of Evolocumab | Day 1 to Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Day 1 to Day 64 | |
| Number of Participants with Serious Adverse Events | Up to Day 64 | |
| Number of Participants with Anti-evolocumab Antibody Formation |
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Inclusion Criteria
Male or female, of any race, between 18 and 60 years of age, inclusive.
a. Females must not be pregnant or lactating.
Body Mass Index (BMI) between 18.0 and 32.0 kg/m^2 inclusive.
LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | 32117-5116 | United States | ||
| QPS Bio-Kinetic |
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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 trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) 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 trial.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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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| Evolocumab Drug Substance B | Drug | Evolocumab drug substance B will be administered SC. |
|
|
| Day 1 and Day 64 |
| Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C) | Day 1 to Day 64 |
| Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | Day 1 to Day 64 |
| Springfield |
| Missouri |
| 65802-4842 |
| United States |
| Ohio Clinical Trials, Inc. | Columbus | Ohio | 43212 | United States |
| Fortrea Clinical Research Unit - Dallas | Dallas | Texas | 75247 | United States |
| Fortrea Clinical Research Unit Inc. - Madison | Madison | Wisconsin | 53704-2526 | United States |
| ID | Term |
|---|---|
| C577155 | evolocumab |
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