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The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]CCX168 | Experimental | Participants will receive a single oral dose of [14C]CCX168 100 mg containing 400 μCi of [14C] on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]CCX168 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine | Up to Day 15 | |
| Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 | |
| Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
Healthy adult males will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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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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| Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood | Up to Day 10 |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood | Up to 24 hours |
| Cmax of CCX168 and Metabolites in Plasma | Up to Day 10 |
| Tmax of CCX168 and Metabolites in Plasma | Up to Day 10 |
| λz of CCX168 and Metabolites in Plasma | Up to Day 10 |
| t½z of CCX168 and Metabolites in Plasma | Up to Day 10 |
| CL/F of CCX168 and Metabolites in Plasma | Up to Day 10 |
| Vz/F of CCX168 and Metabolites in Plasma | Up to Day 10 |
| AUC0-t of CCX168 and Metabolites in Plasma | Up to Day 10 |
| AUCinf of CCX168 and Metabolites in Plasma | Up to Day 10 |
| AUC0-24 of CCX168 and Metabolites in Plasma | Up to 24 hours |
| Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus | Up to Day 15 |
| Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus | Up to Day 15 |
| Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf) | Up to Day 15 |
| Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf) | Up to Day 15 |
| Renal Clearance (CLR) of [14C]CCX168 | Up to Day 15 |
| Renal Clearance of [14C]-Metabolite (CLRmx) | Up to Day 15 |
| Number of Participants Experiencing Adverse Events (AEs) | Up to Day 29 |
| Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters | Up to Day 29 |
| Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters | Up to Day 29 |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003240 | Connective Tissue Diseases |
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