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
| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive 4 X 25 mg tablets of casdatifan. |
|
| Treatment B | Experimental | Participants will receive 1 X 100 mg tablets of casdatifan. |
|
| Treatment C | Experimental | Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casdatifan | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration for casdatifan | Up to 168 hours post each dose | |
| Area under the concentration-time curve for casdatifan | Up to 168 hours post each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax (Tmax) for casdatifan | Up to 168 hours post each dose | |
| Lag time (Tlag) for casdatifan | Up to 168 hours post each dose | |
| Apparent first-order terminal elimination rate constant (Kel) for casdatifan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | +1-510-462-3330 | ClinicalTrialInquiry@arcusbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Tempe | Arizona | 85283 | United States |
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
For more information, please visit our website.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 168 hours post each dose |
| Percent of AUC0-inf extrapolated for casdatifan | Up to 168 hours post each dose |
| Apparent first-order terminal elimination half-life (t½) for casdatifan | Up to 168 hours post each dose |
| Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan | Up to 168 hours post each dose |
| Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan | Up to 168 hours post each dose |
| Number of participants experiencing Adverse Events (AEs) | Up to 43 days |