Clinical trial · Interventional
Effect of Neomycin on the Pharmacokinetics of Regorafenib
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
NCT02001909CI-TRIAL-00018832completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neomycin | Drug | — | UNRESOLVED |
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regorafenib
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
- type
- EXPERIMENTAL
- label
- Neomycin
- interventionNames
- Drug: Neomycin
Primary outcomes (2)
- measure
- AUC (area under the plasma concentration vs. time curve) for regorafenib
- timeFrame
- Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose
- measure
- Cmax (maximum drug concentration) for regorafenib
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion: * Healthy male subjects * Age: 18 to 45 years (inclusive) at the first screening examination/visit * Body mass index (BMI): above/equal 18 and below 30 kg / m² * Confirmation of the subject's health insurance coverage prior to the first screening examination/visit * Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy. Exclusion: * Known or suspected hypersensitivity to regorafenib and/or neomycin * Any illness or medical condition that is unstable or could jeopardize the safety of the subject and his compliance in the study * Clinically significant illness within 30 days prior to Day 1, Period 1. * Regular use of medicines at the time of screening, including herbal supplements and high dose vitamins * Smoking; however, former smokers who have stopped smoking at least 3 months before the first study drug administration may be included * Clinically relevant findings in the electrocardiogram (ECG) * Clinically relevant findings in the complete physical examination * Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) at screening. * Positive urine drug screening
References
Publications (0)
Data not yet available
No reference posted for this study.