NCT02457351

Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients. To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients

Conditions

• Medical Oncology

Interventions

Type	Name	Description
DRUG	Roniciclib (BAY 1000394)	Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data) Part 1 \& Part 2 Cycle 2 and subsequent 21-day cycles: Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose
DRUG	Itraconazole (Sporanox)	Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2015-05-29
• Last updated: 2016-05-23

Locations

4 sites across 1 country: Canada