EndometriosisPhase 1NCT02975440
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
A Phase 1 study testing Rifampicin, Midazolam and BAY1002670_Vilaprisan in people with Endometriosis, run by Bayer at 1 site in Germany.
Trial summary
This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Rifampicin, Midazolam and BAY1002670_Vilaprisan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2016to 11 Apr 2017
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female postmenopausal subjects
- Age: 45 to 65 years (inclusive)
- Body mass index (BMI) : ≥20 and ≤32 kg/m²
- Race: White
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Relevant diseases within the last 4 weeks prior to the first drug administration
- Existing chronic diseases requiring medication
- Known or suspected malignant tumors (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Regular use of medicines
- Repeated use of drugs during 1 week before first study drug administration which might affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-randomized, Non-blinded, Non-placebo-controlled Study to Investigate the Influence of Repeated Daily Administration of 600 mg Rifampicin Given Once Daily Over 11 Days on the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of 4 mg Vilaprisan in Healthy Postmenopausal Women.
This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.
- Conditions
- Endometriosis
- Being tested
- Rifampicin, Midazolam, BAY1002670_Vilaprisan
- Keywords
- Vilaprisan, PK, rifampicin, midazolam,, CYP3A4 induction, drug-drug interaction
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
MidazolamDrug
2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
BAY1002670_VilaprisanDrug
2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days Receives: Drug: Rifampicin; Drug: Midazolam; Drug: BAY1002670_Vilaprisan |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Vilaprisan in plasma with co-medication Rifampicin
Measured: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
Cmax of Vilaprisan in plasma with co-medication Rifampicin
Measured: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
AUC of Vilaprisan in plasma without co-medication Rifampicin
Measured: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
Cmax of Vilaprisan in plasma without co-medication Rifampicin
Measured: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start10 Nov 2016
- Primary completion27 Jan 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02975440
- Sponsor's protocol ID
- 17773
- Status last verified
- Jun 2017
- First submitted
- 4 Nov 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized, Non-blinded, Non-placebo-controlled Study to Investigate the Influence of Repeated Daily Administration of 600 mg Rifampicin Given Once Daily Over 11 Days on the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of 4 mg Vilaprisan in Healthy Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT02975440
- Acronym / sponsor ID
- 17773
- Conditions
- Endometriosis
- Keywords
- Vilaprisan, PK, rifampicin, midazolam,, CYP3A4 induction, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 29 Nov 2016 (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.
This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Rifampicin, Drug: Midazolam, Drug: BAY1002670_VilaprisanTreatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female postmenopausal subjects
- Age: 45 to 65 years (inclusive)
- Body mass index (BMI) : ≥20 and ≤32 kg/m²
- Race: White
Key exclusion criteria (7 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Relevant diseases within the last 4 weeks prior to the first drug administration
- Existing chronic diseases requiring medication
- Known or suspected malignant tumors (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
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 |
|---|---|---|
| Rifampicin11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin. | Drug | Treatment |
| Midazolam2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam | Drug | Treatment |
| BAY1002670_Vilaprisan2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan | Drug | Treatment |
Primary outcome
AUC of Vilaprisan in plasma with co-medication Rifampicin
Time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
Cmax of Vilaprisan in plasma with co-medication Rifampicin
Time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
AUC of Vilaprisan in plasma without co-medication Rifampicin
Time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
Cmax of Vilaprisan in plasma without co-medication Rifampicin
Time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
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 2 Jul 2017.
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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 Rifampicin, Midazolam and BAY1002670_Vilaprisan in people with Endometriosis, run by Bayer at 1 site in Germany.
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 4 inclusion and 7 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 2 Jul 2017. 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 Germany. 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?
AUC of Vilaprisan in plasma with co-medication Rifampicin (time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days). The study lists 4 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 2 Jul 2017.