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NCT02975440
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
Phase 1 trial testing Rifampicin in Endometriosis in 12 participants. Completed in 11 April 2017.
27 January 2017
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 10 November 2016 |
| Primary completion | 27 January 2017 |
| Estimated completion | 11 April 2017 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Rifampicin (Rifampicin) — full drug profile →
- Midazolam (midazolam) — full drug profile →
- BAY1002670_Vilaprisan — full drug profile →
Conditions studied
- Endometriosis — all drugs for Endometriosis →
Sponsor
Bayer — full company profile →
Who can join
Adults 45 to 65, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
CYP3A4-mediated effects of rifampicin on the pharmacokinetics of vilaprisan and its UGT1A1-mediated effects on bilirubin glucuronidation in humans.
Chattopadhyay N, Kanacher T, Casjens M, Frechen S, et al · · 2018 · cited 19× · PMID 30171692 · DOI 10.1111/bcp.13750 -
Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200
Verify or expand the search:
- PubMed search for NCT02975440
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02975440 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02975440.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing