Clinical trial · Interventional
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
- 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 study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations. Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Resistant Prostate Cancer (CRPC) | Castration-Resistant Prostate Carcinoma | ALIAS | 0.85 |
| Healthy Subjects | — | UNRESOLVED | — |
| MDV3100 | — | UNRESOLVED | — |
| Relative Bioavailability | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDV3100 | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment A
- description
- Single dose of 4 liquid-filled capsules of MDV3100 reference formulation
- interventionNames
- Drug: MDV3100
- type
- EXPERIMENTAL
- label
- Treatment B
- description
- Single dose of 2 tablets of MDV3100 formulation tablet B
- interventionNames
- Drug: MDV3100
- type
- EXPERIMENTAL
- label
- Treatment C
- description
- Single dose of 2 tablets of MDV3100 formulation tablet C
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening). * Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration. * Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration. Exclusion Criteria: * Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used. * Confirmed CYP2C8 poor metabolizer status based on genotyping analysis. * Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure. * The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in. * Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject. * Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
References
Publications (0)
Data not yet available