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Rifampicin

Phase 1

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

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Rifampicin · 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 Rifampicin

What is Rifampicin used for in endometriosis?

Rifampicin is a small molecule being investigated for use in endometriosis. It is currently in Phase 1 clinical development. The drug is being studied in a drug-drug interaction trial with vilaprisan, which has been completed. Rifampicin is not approved for this indication and remains investigational.

What does Rifampicin target?

Rifampicin is a small molecule antibiotic that works by inhibiting bacterial DNA-dependent RNA polymerase. However, its mechanism of action in the context of endometriosis is not specified. The drug is being studied for its potential effects in this condition, but the specific molecular target in endometriosis has not been disclosed.

Who makes Rifampicin?

Rifampicin is being developed by Bayer AG, a German pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical research on Rifampicin for the treatment of endometriosis.

What phase is Rifampicin in?

Rifampicin is in Phase 1 clinical development for endometriosis. It is an investigational drug and has not been approved by regulatory authorities for this indication. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical research.

What clinical trials is Rifampicin in?

Rifampicin has one completed clinical trial, NCT02975440, titled 'Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan'. This Phase 1 trial enrolled 12 female participants aged 45 years and older in Germany. The study was uncontrolled and not randomized or double-blinded.

Is Rifampicin the same as other drugs?

Rifampicin is also known as rifampin in some regions. It is a well-established antibiotic used to treat various bacterial infections, including tuberculosis. However, its use in endometriosis is investigational and not yet approved. The drug is being studied for potential new applications beyond its established antibiotic use.