drugset / Trial / NCT03333824
Effects of AZD1775 on the PK Substrates for CYP3A, CYP2C19, CYP1A2 and on QT Interval in Patients With Advanced Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether AZD1775 has any effect on the pharmacokinetics (PK) of three compounds (caffeine, omeprazole, and midazolam) that are probes for common drug-metabolizing enzymes (caffeine-CYP1A2, omeprazole-CYP2C19, midazolam-CYP3A). The study also seeks to determine the effect of AZD1775 on the QTc interval, which is a common measure of cardiac (heart) function.
Timeline
- Start
- 2017-12-01
- Primary completion
- 2019-01-22
- Completion
- 2019-01-22
Publications
- Nagard M, Ah-See ML, Strauss J, Wise-Draper T, Safran HP, Nadeau L, Edenfield WJ, Lewis LD, Ottesen LH, Li Y, Mugundu GM. Phase I study to assess the effect of adavosertib (AZD1775) on the pharmacokinetics of substrates of CYP1A2, CYP2C19, and CYP3A in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2023 Sep;92(3):193-203. doi: 10.1007/s00280-023-04554-3. Epub 2023 Jul 2.
- Nagard M, Ah-See ML, Strauss J, Wise-Draper T, Safran HP, Nadeau L, Edenfield WJ, Lewis LD, Rekic D, Dota C, Ottesen LH, Li Y, Mugundu GM. Adavosertib (AZD1775) does not prolong the QTc interval in patients with advanced solid tumors: a phase I open-label study. Cancer Chemother Pharmacol. 2023 Aug;92(2):141-150. doi: 10.1007/s00280-023-04555-2. Epub 2023 Jun 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adavosertib | Small molecule | 225 mg | Oral |
| Subject | Caffeine | Small molecule | 200 mg | — |
| Subject | Midazolam | Small molecule | 2 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Background | Granisetron | Other / unclassified | 1 mg | Oral |