Clinical trial · Interventional
A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer
An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT01017939CI-TRIAL-00010023completedPhase 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)
The purpose of this study is to evaluate the effects of multiple doses of abiraterone acetate plus prednisone on the pharmacokinetics (study of what the body does to a drug) of single doses of dextromethorphan hydrobromide and theophylline in patients with castration resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Dextromethorphan hydrobromide | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Theophylline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: abiraterone + prednisone + dextromethorphan
- description
- Group A will assess the effect of multiple doses of abiraterone acetate plus prednisone on CYP2D6 using 2 single doses of dextromethorphan hydrobromide as a probe drug.
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone
- Drug: Dextromethorphan hydrobromide
- type
- EXPERIMENTAL
- label
- Group B: abiraterone + prednisone + theophylline
- description
- Group B will assess the effect of multiple doses of abiraterone acetate plus prednisone on CYP1A2 using 2 single doses of theophylline as a probe drug.
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone
- Drug: Theophylline
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Documented metastatic disease * Documented prostate specific antigen (PSA) progression according to Prostate Cancer Working Group 2 criteria, with PSA value \>=2 ng/mL despite medical or surgical castration, or prostate cancer progression documented by radiographic progression according to Response Evaluation Criteria In Solid Tumors criteria * Surgically or medically castrated with testosterone levels of \<50 ng/dL * Eastern Cooperative Oncology Group (ECOG) Performance Status of \<=2 * Group A only: genomic testing at screening indicating CYP2D6 extensive metabolizer status * Protocol-defined laboratory values Exclusion Criteria: * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Group A only: genomic testing at screening indicating CYP2D6 non-extensive metabolizer status, or prior treatment with dextromethorphan-containing medication or any medication that is a strong inhibitor or inducer of CYP2D6 within 5 half-lives of that drug or 7 days, whichever is longer, prior to Cycle 1 Day -8 * Group B only: prior treatment with theophylline or any medication that is a strong inhibitor or inducer of CYP1A2 within 5 half-lives of that drug or 7 days, whichever is longer, prior to Cycle 1 Day -8 * Abnormal liver function * Uncontrolled hypertension (repeated systolic blood pressure \>=160 mmHg, or diastolic blood pressure \>=95 mmHg) * Active or symptomatic viral hepatitis or chronic liver disease * Known brain metastasis * History of pituitary or adrenal dysfunction * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of \<50% at baseline * History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug * Surgery or local prostatic intervention within 28 days of the first dose, and any clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day 1 * Radiotherapy or immunotherapy within 28 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1 * Any acute toxicities due to prior therapy that have not resolved * Current enrollment in an investigational drug or device study or participation in such a study within 28 days of Cycle 1 Day 1 * Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700)
References
Publications (0)
Data not yet available
No reference posted for this study.