Clinical trial · Interventional
Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients
A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer
NCT01902251CI-TRIAL-00015566completedPhase 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)
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
Conditions
Conditions (2)
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 Enzalutamide | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide capsule | Drug | Enzalutamide | ALIAS |
| Enzalutamide tablet | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzalutamide tablet
- description
- Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks
- interventionNames
- Drug: Enzalutamide tablet
- type
- ACTIVE_COMPARATOR
- label
- Enzalutamide capsule
- description
- Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks
- interventionNames
- Drug: Enzalutamide capsule
Primary outcomes (2)
- measure
- Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 orchiectomy (i.e., medical or surgical castration) at study entry. * Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria: * PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL); * Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease * Bone disease progression defined by two or more new lesions on bone scan Exclusion Criteria: * Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study. * History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit). * Patients who previously received treatment with Enzalutamide. * Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8. * Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
References
Publications (0)
Data not yet available
No reference posted for this study.