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The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose 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 |
|---|---|---|---|
| Group 1, AMG 133: Normal Hepatic Function (No Impairment) | Experimental | Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1. |
|
| Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment) | Experimental | Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
|
| Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment) | Experimental | Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
|
| Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment) | Experimental | Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 133 | Drug | Participants will receive AMG 133 SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of AMG 133 | Up to Day 120 | |
| Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133 | Up to Day 120 | |
| AUC from Time Zero to Infinity (AUCinf) of AMG 133 | Up to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) | Up to Day 120 | |
| Number of Participants Who Experience Serious Adverse Events (SAEs) | Up to Day 120 | |
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Inclusion Criteria:
Adults 18 to 75 years of age, male or female.
Body mass index ≥ 22 kg/m^2 at screening.
For participants with normal hepatic function:
For participants with hepatic impairment:
Willing to use reliable contraception (if of childbearing potential) or practice abstinence through 16 weeks after dosing.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Of Miami, LLC | Miami | Florida | 33172 | United States | ||
| Panax Clinical Research |
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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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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Number of Participants Who Develop Anti-AMG 133 Antibodies |
| Up to Day 120 |
| Miami Lakes |
| Florida |
| 33014-2811 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| The Texas Liver Institute, Inc. | San Antonio | Texas | 78215-2100 | United States |
| Pinnacle Clinical Research San Antonio | San Antonio | Texas | 78229-4801 | United States |