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A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Severely Renal Impaired Participants | Experimental | Participants with severely impaired renal function (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m^2) receive a single oral dose of 200 mg AMG 986. |
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| Group 2: Healthy Participants | Active Comparator | Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) receive a single oral dose of 200 mg AMG 986. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 986 | Drug | tablets for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast) | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose | |
| AMG 986 PK Parameter: Maximum Observed Plasma Concentration After Dosing (Cmax) | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose | |
| AMG 986 PK Parameter: Terminal Phase Half-Life (t1/2,z) | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose | |
| AMG 986 PK Parameter: Time of Maximum Plasma Concentration (Tmax) | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose | |
| AMG 986 PK Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUCinf) | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event is defined as any untoward medical occurrence in a clinical trial subject. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tustin | California | 92780 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35092583 | Background | Trivedi A, Mather O, Vega S, Simiens MA, Hellawell J, Lee E. Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986. Drugs R D. 2022 Mar;22(1):89-94. doi: 10.1007/s40268-021-00380-1. Epub 2022 Jan 29. |
| 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 (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 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, 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 link below.
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This study was conducted in 4 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Severely Renal Impaired Participants | Participants with severely impaired renal function (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986. |
| FG001 | Group 2: Healthy Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2017 | Jan 8, 2021 |
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This is a multisite (approximately 3 sites), open-label, non-randomized, single-dose study in participants with severely impaired kidney function and healthy participants. About 12 participants will be assigned to two groups: Group 1: 6 with severely impaired kidney function , and Group 2: 6 with normal kidney function.
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The patient, investigator, investigative staff, medical monitor and care provider will not be masked for the study.
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| From first dose of study drug up to Day 30 |
| Orlando |
| Florida |
| 32809 |
| United States |
| Research Site | Minneapolis | Minnesota | 55404 | United States |
| Research Site | San Antonio | Texas | 78215 | United States |
Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986. |
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| NOT COMPLETED |
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The safety analysis set included all study participants who received at least 1 dose of AMG 986.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Severely Renal Impaired Participants | Participants with severely impaired renal function (eGFR 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986. |
| BG001 | Group 2: Healthy Participants | Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast) | The PK analysis set included all participants for whom at least 1 PK parameter or endpoint could be reliably estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
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| Primary | AMG 986 PK Parameter: Maximum Observed Plasma Concentration After Dosing (Cmax) | The PK analysis set included all participants for whom at least 1 PK parameter or endpoint could be reliably estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
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| Primary | AMG 986 PK Parameter: Terminal Phase Half-Life (t1/2,z) | The PK analysis set included all participants for whom at least 1 PK parameter or endpoint could be reliably estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
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| Primary | AMG 986 PK Parameter: Time of Maximum Plasma Concentration (Tmax) | The PK analysis set included all participants for whom at least 1 PK parameter or endpoint could be reliably estimated. | Posted | Median | Full Range | hours | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
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| Primary | AMG 986 PK Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUCinf) | The PK analysis set included all participants for whom at least 1 PK parameter or endpoint could be reliably estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event is defined as any untoward medical occurrence in a clinical trial subject. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
| The safety analysis set included all study participants who received at least 1 dose of AMG 986. | Posted | Number | participants | From first dose of study drug up to Day 30 |
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From first dose of study drug up to Day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Severely Renal Impaired Participants | Participants with severely impaired renal function (eGFR 15 to 29 mL/min/1.73 m^2) received a single oral dose of 200 mg AMG 986. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG001 | Group 2: Healthy Participants | Participants with normal renal function (eGFR >= 90 mL/min/1.73 m^2 or above) received a single oral dose of 200 mg AMG 986. | 0 | 6 | 0 | 6 | 1 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2018 | Jan 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D006331 | Heart Diseases |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black (or African American) |
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| White |
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