drugset / Trial / NCT02975440

Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

NCT02975440

Phase 1 Completed 12 enrolled Bayer
NaSingle-groupOpen-labelBasic science

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 (probe) substance.

Timeline

Start
2016-11-10
Primary completion
2017-01-27
Completion
2017-04-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 1 mg Oral
Subject Rifampin Small molecule 600 mg Oral
Subject Vilaprisan Other / unclassified 4 mg Oral

Indications