(22081) Open-label, fixed sequence crossover study to determine the effects of a single dose of elinzanetant (BAY 3427080) on the pharmacokinetics of dabigatran etexilate in healthy participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500201-41-00

Acronym

22081

Enrollment

Registered

2022-07-28

Start date

2022-08-02

Completion date

2022-11-14

Last updated

2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)

Brief summary

Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of EZN, AUC of unconjugated and total dabigatran when given without or together with a single oral dose of EZN, or AUC(0-tlast) if AUC cannot be determined in all participants

Detailed description

Number of participants with and severity of treatment-emergent adverse events (TEAEs)

Interventions

DRUGPradaxa 75 mg hard capsules

DRUGBAY 3427080

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cmax of unconjugated and total dabigatran when given without or together with a single oral dose of EZN, AUC of unconjugated and total dabigatran when given without or together with a single oral dose of EZN, or AUC(0-tlast) if AUC cannot be determined in all participants	—

Secondary

Measure	Time frame
Number of participants with and severity of treatment-emergent adverse events (TEAEs)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026