Trial Condition(s):
Neoplasms
Effect of neomycin on the pharmacokinetics of regorafenib
Bayer Identifier:
16675
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
27
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-center, open-label, non-randomized, two-period sequential treatment study to assess the effect of neomycin on the pharmacokinetics of regorafenib in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Regorafenib after a single doseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Maximum Observed Drug Concentration (Cmax) of Regorafenib after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
Secondary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- AMaximum Observed Drug Concentration (Cmax) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Time to Reach Maximum Drug Concentration in Plasma (tmax) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Time of Last Concentration (tlast) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Terminal Half Life Associated With the Terminal Slope (t1/2) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC[024]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Area Under the Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single DoseTimeframe: Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
- Amount of Drug Excreted into Urine from 0 to 24 hours (AE,ur[0–24]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)Timeframe: Urine collection interval: 0-24 hours
- Amount of Drug Excreted into Urine from 0 to 72 hours (AE,ur[0–72]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)Timeframe: Urine collection interval: 0-72 hours
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