PharmacokineticsPhase 1NCT01318265
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
A Phase 1 study testing Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole in people with Pharmacokinetics, run by Bayer at 1 site in United States.
Trial summary
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 45 years of age, inclusive
- BMI between 18 and 32 kg/m2 inclusive
Who cannot join
- Subjects with evidence of disease, conditions affecting drug absorption or metabolism
- Treatment with other investigational drug within 30 days
- History of regular alcohol or recreational drug consumption
- Use of prescription drugs within 14 days
- Use of nonprescription drugs and dietary supplement within 7 days
- Blood donation within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
- Conditions
- Pharmacokinetics
- Being tested
- Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
- Keywords
- drug interactions, ketoconazole, pharmacokinetics, human volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazoleDrug
Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Not described Receives: Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.
Measured: 1 month
Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
Measured: 1 month
Secondary outcomes (3)
Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
Measured: 1 month
Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
Measured: 1 month
Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318265
- Sponsor's protocol ID
- 12435
- Status last verified
- Oct 2014
- First submitted
- 18 Feb 2011
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01318265
- Acronym / sponsor ID
- 12435
- Conditions
- Pharmacokinetics
- Keywords
- drug interactions, ketoconazole, pharmacokinetics, human volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between 18 and 45 years of age, inclusive
- BMI between 18 and 32 kg/m2 inclusive
Key exclusion criteria (6 listed)
- Subjects with evidence of disease, conditions affecting drug absorption or metabolism
- Treatment with other investigational drug within 30 days
- History of regular alcohol or recreational drug consumption
- Use of prescription drugs within 14 days
- Use of nonprescription drugs and dietary supplement within 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazoleTreatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1. | Drug | Arm1 |
Primary outcome
Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.
Time frame: 1 month
Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
Time frame: 1 month
3 secondary outcomes
Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
Time frame: 1 month
Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.
Time frame: 1 month
Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole in people with Pharmacokinetics, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.