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NCT05076877 · ClinicalTrials.gov registry record · Phase 1
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05076877: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT05076877 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05076877, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.
Primary Outcome
Plasma samples will be analyzed to determine concentrations of midazolam and its metabolite 1-OH-midazolam, rosuvastatin, metformin, or lazertinib using a validated, specific, and sensitive method on Day 1 versus Day 13 as a part of drug-drug interaction (DDI) assessment.
Interventions
- DRUG Midazolam
- DRUG Metformin
- DRUG Rosuvastatin
- DRUG Lazertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-09-17 |
| Est. Completion | 2022-02-10 |
| Phase | Phase 1 |
What the finished NCT05076877 record still lists
NCT05076877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT05076877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05076877 about?
NCT05076877 is a clinical study titled "A Study of Lazertinib (JNJ-73841937) in Healthy Participants". The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.
What is the current status of trial NCT05076877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-09-17. Estimated completion is 2022-02-10.
What interventions are being tested in trial NCT05076877?
The interventions under investigation include: Midazolam (DRUG), Metformin (DRUG), Rosuvastatin (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT05076877?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05076877's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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