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NCT03028103 · ClinicalTrials.gov registry record · Phase 1
Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
A Phase 1 study, sponsored by Epizyme.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03028103 is a Phase 1 study that has completed, run by Epizyme. The registered enrollment target is 32 participants.
The verdict
NCT03028103, a Phase 1 study, has completed, sponsored by Epizyme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
Interventions
- DRUG Fluconazole
- DRUG Omeprazole
- DRUG Tazemetostat
- DRUG Repaglinide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2019-11-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03028103
The ClinicalTrials.gov registry entry for NCT03028103 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epizyme, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fluconazole is the first listed.
NCT03028103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03028103 about?
NCT03028103 is a clinical study titled "Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients". This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
What is the current status of trial NCT03028103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-03-27. Estimated completion is 2019-11-29.
What interventions are being tested in trial NCT03028103?
The interventions under investigation include: Fluconazole (DRUG), Omeprazole (DRUG), Tazemetostat (DRUG), Repaglinide (DRUG).
Who is sponsoring clinical trial NCT03028103?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
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