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BAY1002670_Vilaprisan

Phase 1

Endometriosis | Small molecule | Endocrine |Bayer AG|Trials Updated: Jul 2, 2017

BAY1002670_Vilaprisan development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

BAY1002670_Vilaprisan clinical trials

BAY1002670_Vilaprisan · 1 trial · 1 indication

Phase 1 1
NCT02975440Drug-drug Interaction Study Between Orally Administered Rifampicin and VilaprisanEndometriosis
COMPLETED12 Analytics
PHASE1COMPLETED
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC of Vilaprisan in plasma with co-medication Rifampicin
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
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
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
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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTALTreatment 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

Interventions

NameTypeDescription
RifampicinDRUG11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
MidazolamDRUG2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
BAY1002670_VilaprisanDRUG2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
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Eligibility Criteria

Age Range45 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female postmenopausal subjects * Age: 45 to 65 years (inclusive) * Body mass index (BMI) : ≥20 and ≤32 kg/m² * Race: White Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinica...

Countries:Germany
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Frequently asked questions about BAY1002670_Vilaprisan

What is BAY1002670_Vilaprisan?

BAY1002670_Vilaprisan is an investigational small molecule developed by Bayer AG for endometriosis, an endocrine condition. It is in Phase 1 clinical development and has been studied in a completed drug-drug interaction trial. It is not described as approved.

What is BAY1002670_Vilaprisan used for in endometriosis?

BAY1002670_Vilaprisan is being developed for endometriosis, a condition in which tissue similar to the uterine lining grows outside the uterus. The clinical program has focused on this indication, with a completed Phase 1 drug-drug interaction study conducted in Germany.

Who makes BAY1002670_Vilaprisan?

BAY1002670_Vilaprisan is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program for this investigational small molecule in endometriosis.

What phase is BAY1002670_Vilaprisan in?

BAY1002670_Vilaprisan is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational agent and is not described as approved for any indication.

What clinical trials is BAY1002670_Vilaprisan in?

BAY1002670_Vilaprisan has been studied in one completed Phase 1 trial, NCT02975440, titled a drug-drug interaction study between orally administered rifampicin and vilaprisan. The trial enrolled 12 participants in Germany, was uncontrolled, and included healthy female volunteers aged 45 years and older.

Is BAY1002670_Vilaprisan the same as vilaprisan?

Yes, BAY1002670_Vilaprisan is also known as vilaprisan. The two names refer to the same investigational small molecule developed by Bayer AG for endometriosis, and the completed Phase 1 trial NCT02975440 uses the vilaprisan name.