LeiomyomaPhase 1NCT03092999
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
A Phase 1 study testing Vilaprisan (BAY1002670) in people with Leiomyoma, run by Bayer at 2 sites in Germany.
Trial summary
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan) Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Vilaprisan (BAY1002670)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- 28 Mar 2017to 17 Jul 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- The informed consent must be signed before any study specific tests or procedures are done
- White/Caucasian men and women aged between 18 to 79 years (inclusive )
- Body mass index (BMI): 18 to 34 kg/m2 (both inclusive)
- Ability to understand and follow study-related instructions
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and three months after administration of study drug. Subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active.
Show all 11Show fewer
- This is not required if safe contraception is achieved by a permanent method, such as hysterectomy, bilateral fallopian tube ligation or vasectomy.
- For subjects with hepatic impairment:
- Subjects with documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, or ultrasound
- Subjects with hepatic impairment (Child-Pugh A or B)
- Subjects with stable liver disease, i.e. same Child-Pugh class in the last 2 months
Who cannot join
- Any relevant disease within 4 weeks prior to study drug administration requiring medical treatment
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Use containing sex hormones within 4 weeks to six months before first study drug administration
- Use of CYP3A4 and P-glycoprotein inhibitors or inducers
- Use of drugs which may affect absorption
- Major change of medication <2 weeks prior study drug administration
- Deviations from normal range in physical examination, gynecological examination, clinical chemistry, hematology, or urinalysis considered to be relevant by the investigator
- Any criteria which, in the opinion of the investigator, make study participation unadvisable for scientific, compliance, safety, or medical reasons
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
Universitätsklinikum Schleswig-Holstein / AÖR
Lübeck, 23538
About this study
Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of Vilaprisan (BAY1002670) in Subjects With Hepatic Impairment (Classified as Child-Pugh A or B) Compared to Sex, Age, and Weight-matched Healthy Subjects Following a Single Oral Dose
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
- Conditions
- Leiomyoma
- Being tested
- Vilaprisan (BAY1002670)
- Keywords
- Pharmacokinetics
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY1002670)Drug
2 mg tablet, single dose, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | healthy subjects Receives: Drug: Vilaprisan (BAY1002670) |
| Subjects with mild hepatic impairment | Experimental | hepatically impaired patients (classified as Child Pugh A) Receives: Drug: Vilaprisan (BAY1002670) |
| Subjects with moderate hepatic impairment | Experimental | hepatically impaired patients (classified as Child Pugh B) Receives: Drug: Vilaprisan (BAY1002670) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Exposure of Vilaprisan in plasma following a single dose administration
Measured: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Maximum observed (unbound) drug concentration (Cmax,u)
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
Measured: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Secondary outcomes (6)
Frequency of Treatment Emergent Adverse Events
Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
Measured: Up to 20 days
Severity of Treatment Emergent Adverse Events
The intensity of an AE is classified according to the following categories:
- Mild
- Moderate
- Severe
Measured: Up to 20 days
Changes in blood laboratory parameters
Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
Measured: Up to 20 days
Changes in urine laboratory parameters
Changes in urine laboratory parameters including urine analysis, urine pregnancy tests
Measured: Up to 20 days
Changes in Vital Signs
Changes in Vital Signs, including blood pressure, pulse, body temperature
Measured: Up to 20 days
Changes in Electrocardiogram (ECG)
ECG (12-lead) after ≥10 minutes supine rest
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start28 Mar 2017
- Primary completion17 Jul 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT03092999
- Sponsor's protocol ID
- 15251
- Other IDs
- 2015-005232-18, 2015
- Status last verified
- Jul 2017
- First submitted
- 22 Mar 2017
- Last updated
- 18 Aug 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 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety, and Tolerability of Vilaprisan (BAY1002670) in Subjects With Hepatic Impairment (Classified as Child-Pugh A or B) Compared to Sex, Age, and Weight-matched Healthy Subjects Following a Single Oral Dose
- ClinicalTrials.gov ID
- NCT03092999
- Acronym / sponsor ID
- 15251
- Conditions
- Leiomyoma
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Drug: Vilaprisan (BAY1002670)healthy subjects |
| Subjects with mild hepatic impairment | Experimental | Drug: Vilaprisan (BAY1002670)hepatically impaired patients (classified as Child Pugh A) |
| Subjects with moderate hepatic impairment | Experimental | Drug: Vilaprisan (BAY1002670)hepatically impaired patients (classified as Child Pugh B) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The informed consent must be signed before any study specific tests or procedures are done
- White/Caucasian men and women aged between 18 to 79 years (inclusive )
- Body mass index (BMI): 18 to 34 kg/m2 (both inclusive)
- Ability to understand and follow study-related instructions
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and three months after administration of study drug. Subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active.
Key exclusion criteria (8 listed)
- Any relevant disease within 4 weeks prior to study drug administration requiring medical treatment
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Use containing sex hormones within 4 weeks to six months before first study drug administration
- Use of CYP3A4 and P-glycoprotein inhibitors or inducers
- Use of drugs which may affect absorption
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 |
|---|---|---|
| Vilaprisan (BAY1002670)2 mg tablet, single dose, oral administration | Drug | Healthy subjects, Subjects with mild hepatic impairment, Subjects with moderate hepatic impairment |
Primary outcome
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Exposure of Vilaprisan in plasma following a single dose administration
Maximum observed (unbound) drug concentration (Cmax,u)
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
6 secondary outcomes
Frequency of Treatment Emergent Adverse Events
Time frame: Up to 20 days
Severity of Treatment Emergent Adverse Events
Time frame: Up to 20 days
Changes in blood laboratory parameters
Time frame: Up to 20 days
Changes in urine laboratory parameters
Time frame: Up to 20 days
Changes in Vital Signs
Time frame: Up to 20 days
Changes in Electrocardiogram (ECG)
Time frame: Up to 20 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 18 Aug 2017.
Related trials for Leiomyoma
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vilaprisan (BAY1002670) in people with Leiomyoma, run by Bayer at 2 sites 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 11 inclusion and 8 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound) (time frame: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days). 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 18 Aug 2017.