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Open label non-randomized non-controlled mass balance study in Cycle 1

Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles

Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of \[14C\] roniciclib solution

roniciclib (BAY 1000394)

5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days

Bayer Study Director

The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.

Roniciclib Mass Balance Study

A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors

Bayer

Anti-Infective Agents

Itraconazole

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Pharmacokinetics and safety in patients with advanced solid tumor

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

Roniciclib (BAY 1000394)

Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd

Itraconazole (Sporanox)

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

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

Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Roniciclib Mass Balance Study	NCT02390154	Neoplasms	roniciclib (BAY... roniciclib (BAY...	18 Years - 99 Years	Bayer
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study	NCT02457351	Medical Oncolog...	Roniciclib (BAY... Itraconazole (S...	18 Years -	Bayer

Spots Global Cancer Trial Database for roniciclib (bay 1000394)