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NCT04410094 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04410094 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 32 participants.
The verdict
NCT04410094, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
Interventions
- DRUG Rifampin
- DRUG Itraconazole
- DRUG Lazertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04410094
The ClinicalTrials.gov registry entry for NCT04410094 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 Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT04410094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04410094 about?
NCT04410094 is a clinical study titled "A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants". The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
What is the current status of trial NCT04410094?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-09-14. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT04410094?
The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT04410094?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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