drugset / Trial / NCT04312282
The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.
Timeline
- Start
- 2020-03-06
- Primary completion
- 2020-09-30
- Completion
- 2021-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Rifampin | Small molecule | — | Oral |
| Subject | Tesetaxel | Small molecule | — | Oral |