Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | A single dose of 2 mg midazolam (a Cytochrome P450 [CYP]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13. On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19. On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally. |
|
| Cohort B | Experimental | A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCX168 | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam | Up to Day 13 | |
| Cohort A: Cmax of Celecoxib | Up to Day 13 | |
| Cohort A: Time of Cmax (Tmax) of Midazolam | Up to Day 13 | |
| Cohort A: Tmax of Celecoxib | Up to Day 13 | |
| Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam | Up to Day 13 | |
| Cohort A: AUC from Time 0 to infinity of Celecoxib | Up to Day 13 | |
| Cohort A: Apparent Terminal Half Life of Midazolam | Up to Day 13 | |
| Cohort A: Apparent Terminal Half Life of Celecoxib | Up to Day 13 | |
| Cohort A: Cmax of CCX168 | Day 15 up to Day 19 | |
| Cohort A: Tmax of CCX168 | Day 15 up to Day 19 | |
| Cohort A: AUC Over the Dosing Interval of CCX168 | Day 15 up to Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Up to Day 29 | |
| Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters | Up to Day 19 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Midazolam |
| Drug |
Administered orally. |
|
| Celecoxib | Drug | Administered orally. |
|
| Itraconazole | Drug | Administered orally. |
|
| Rifampicin | Drug | Administered orally. |
|
| Cohort B: Cmax of CCX168 | Up to Day 14 |
| Cohort B: Tmax of CCX168 | Up to Day 14 |
| Cohort B: AUC from Time 0 to infinity of CCX168 | Up to Day 14 |
| Cohort B: Apparent Terminal Half Life of CCX168 | Up to Day 14 |
| Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters |
| Up to Day 19 |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D007674 | Kidney Diseases |
| D065766 | Atypical Hemolytic Uremic Syndrome |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620232 | avacopan |
| D008874 | Midazolam |
| D000068579 | Celecoxib |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014230 | Triazoles |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided