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NCT03864042 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT03864042 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 56 participants.
The verdict
NCT03864042, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.
Interventions
- DRUG midazolam
- DRUG dextromethorphan
- DRUG omeprazole
- DRUG caffeine
- DRUG losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2023-05-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03864042
The ClinicalTrials.gov registry entry for NCT03864042 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which midazolam is the first listed.
NCT03864042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03864042 about?
NCT03864042 is a clinical study titled "Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors". This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transp...
What is the current status of trial NCT03864042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2018-01-02. Estimated completion is 2023-05-29.
What interventions are being tested in trial NCT03864042?
The interventions under investigation include: midazolam (DRUG), dextromethorphan (DRUG), omeprazole (DRUG), caffeine (DRUG), losartan (DRUG).
Who is sponsoring clinical trial NCT03864042?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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