Clinical trial · Interventional
A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer
A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates for CYP1A2 and CYP2D6 in Male Subjects With Prostate Cancer
NCT02225093CI-TRIAL-00028286completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates how once daily enzalutamide affects the metabolism of caffeine and dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and their metabolites in plasma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pharmacokinetics of Caffeine | — | UNRESOLVED | — |
| Pharmacokinetics of Dextromethorphan | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caffeine | Drug | — | UNRESOLVED |
| Dextromethorphan | Drug | — | UNRESOLVED |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Enzalutamide Placebo to Match (PTM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1:Caffeine, Dextromethorphan and Enzalutamide
- description
- 1-sequence crossover here
- interventionNames
- Drug: Caffeine
- Drug: Dextromethorphan
- Drug: Enzalutamide
- Drug: Enzalutamide Placebo to Match (PTM)
Primary outcomes (3)
- measure
- PK measured by Pharmacokinetic parameter Maximum concentration (Cmax)
- timeFrame
- Day 1 and Day 53 (28 times)
- description
- For the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide.
- measure
- PK measured by Pharmacokinetic parameter Area under the curve (AUC) from the time of dosing to the last measurable concentration (AUC0-t)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or have undergone prior bilateral orchiectomy at screening. * Subject has progressive disease by prostate-specific antigen (PSA) or imaging. * Subject has received no more than 2 prior chemotherapy regimens. * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Male subject must use a condom if having sex with a pregnant woman. * Male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration. * Subject has an estimated life expectancy of at least 6 months. Exclusion Criteria: * Subject has confirmed CYP2D6 poor metabolizer, or CYP2D6 ultrarapid metabolizer status based on genotyping analysis. * Subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor. * Subject has undergone major surgery within 4 weeks prior to day 1. * Subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study. * Subject uses concomitant medications that are potent inducers and/or inhibitors of CYP1A2, CYP2C8, CYP2D6, or CYP3A4.
References
Publications (0)
Data not yet available
No reference posted for this study.