check_circleStudy Completed
Medical oncology
Bayer Identifier:
17616
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study
Trial purpose
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
To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
14Trial Dates
July 2015 - April 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Roniciclib (BAY1000394)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Edmonton, T6G 1Z2, Canada | |
Completed | Hamilton, L8V 5C2, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | London, N6A 4L6, Canada |
Primary Outcome
- Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole)date_rangeTime Frame:Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosingenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)date_rangeTime Frame:Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosingenhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole)date_rangeTime Frame:Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosingenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole)date_rangeTime Frame:Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosingenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazoledate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazoleComplete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy testdate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazoledate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazoledate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazoledate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazoledate_rangeTime Frame:up to 15 monthsenhanced_encryptionYesSafety Issue:
- Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)date_rangeTime Frame:Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosingenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)date_rangeTime Frame:Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosingenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1