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A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Treatment A (sitravatinib only) | Experimental | Period 1: A single oral dose of 100 mg sitravatinib on Day 1 |
|
| Group 1 Treatment B (sitravatinib and pantoprazole) | Experimental | Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7 |
|
| Group 2 Treatment C (sitravatinib only) | Experimental | Period 1: A single oral dose of 100 mg sitravatinib on Day 1 |
|
| Group 2 Treatment D (sitravatinib and famotidine) | Experimental | Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitravatinib | Drug | 100 mg sitravatinib on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax (sitravatinib) | Maximum observed plasma concentration | Up to Day 7 after dosing |
| Pharmacokinetics - AUC∞ (sitravatinib) | Area under the plasma concentration-time curve from time zero extrapolated to infinity | Up to 72 hours after dosing |
| Pharmacokinetics - AUClast (sitravatinib) | Area under the curve from time zero to the last measured time point | Up to 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Incidence and severity of AEs | Up to 9 weeks from screening |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curtis Chin, MD | Mirati Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000611865 | sitravatinib |
| D000077402 | Pantoprazole |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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2 period crossover
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|
| Pantoprazole | Drug | 40 mg QD on Day 1 to Day 7 of Period 2 in Group 1 |
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| Famotidine | Drug | 40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2 |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |