# Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers

> **NCT03237416** · PHASE1 · COMPLETED · sponsor: **Bayer** · enrollment: 15 (actual)

## Conditions studied

- Prostatic Neoplasms

## Interventions

- **DRUG:** Dabigatran etexilate
- **DRUG:** Midazolam
- **DRUG:** BAY1841788 (darolutamide)

## Key facts

- **NCT ID:** NCT03237416
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-08-02
- **Primary completion:** 2017-10-05
- **Final completion:** 2017-12-18
- **Target enrollment:** 15 (ACTUAL)
- **Last updated:** 2018-11-06

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03237416

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03237416, "Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT03237416. Licensed CC0.

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