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

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

April 30, 2016

Conditions
Medical Oncology
Interventions
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

Trial Locations (4)

T6G 1Z2

Edmonton

L8V 5C2

Hamilton

N6A 4L6

London

H3T 1E2

Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY