Effect of Neomycin on the Pharmacokinetics of Regorafenib

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001909
• Other study ID #: 16675
• Secondary ID: 2013-001721-18
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2013
• Last updated: August 12, 2015
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days
• Neomycin
1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the plasma concentration vs. time curve) for regorafenib		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Primary	Cmax (maximum drug concentration) for regorafenib		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	AUC(0-24) (area under the plasma concentration vs. time curve) for regorafenib		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose	No
Secondary	AUC(0-tlast) (area under the plasma concentration vs. time curve) for regorafenib		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	AUC (area under the plasma concentration vs. time curve) for BAY75-7495 (M-2) and BAY81-8752 (M-5)		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	Cmax (maximum drug concentration) for M-2 and M-5		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	tmax (time to reach maximum drug concentration in plasma after single dose) for regorafenib, M-2 and M-5		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	tlast (time of last concentration above lower limit of quantification) for regorafenib, M-2 and M-5		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	t1/2 (half-life associated with the terminal slope) for regorafenib, M-2 and M-5		Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose	No
Secondary	AE,ur(0-72) (amount of drug excreted via urine during the collection interval 0-72 hours post administration) for metabolites BAY86-6651 (M-7) and BAY86-6652 (M-8)		0-72 hours post dose	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 30 days after last dose	Yes

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