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CompletedNCT01322438Updated Dec 19, 2014

Effect of Rifampin on the Pharmacokinetics of BAY73-4506

A Phase 1 interventional study of Regorafenib (BAY73-4506) + rifampin in Neoplasms, sponsored by Bayer. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-19.

Sponsored by Bayer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.

02

Conditions studied

  • Neoplasms

Keywords

  • healthy volunteers
  • rifampin
  • pharmacokinetics
  • single dose
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening examination / visit
  • Body mass index (BMI): 18 to 32 kg/m² (inclusive)
  • Ability to understand and follow study-related instructions
  • 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 criteria

Exclusion Criteria:

  • Clinically significant disease or condition
  • Recent serious infection
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Regorafenib (BAY73-4506) + rifampin

Interventions

  • DrugRegorafenib (BAY73-4506) + rifampin

    Drug: BAY73-4506 A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 1 as four 40 mg tablets. Drug: BAY73-4506 and rifampin 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 15 to Day 23. A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 21 as four 40 mg tablets.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic profile

    Time frame: after 1 month

  2. Proportion of subjects with adverse event collection

    Time frame: after 35 days

07

Study locations

1 site
  • Austin, Texas 78744, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01322438
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 24, 2011
Start date
Mar 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Dec 19, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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