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NCT04537715 · ClinicalTrials.gov registry record · Phase 1
Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
A Phase 1 study, sponsored by Epizyme.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT04537715: Completed Phase 1 study, sponsored by Epizyme.
NCT04537715 is a Phase 1 study that has completed, run by Epizyme. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04537715, a Phase 1 study, has completed, sponsored by Epizyme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug. Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole. Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.
Primary Outcome
Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
Interventions
- DRUG Rifampin
- DRUG Itraconazole
- DRUG Tazemetostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 1 |
What the finished NCT04537715 record still lists
NCT04537715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT04537715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04537715 about?
NCT04537715 is a clinical study titled "Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels". The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug. Part 1 of the study will e...
What is the current status of trial NCT04537715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-04-23. Estimated completion is 2023-04-03.
What interventions are being tested in trial NCT04537715?
The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT04537715?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04537715's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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