---
title: A Study of Lazertinib (JNJ-73841937) in Healthy Participants
nct_id: NCT05076877
overall_status: COMPLETED
phase: PHASE1
sponsor: Janssen Research & Development, LLC
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05076877.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05076877"
ct_last_update_post_date: 2022-06-27
last_seen_at: "2026-05-12T07:14:10.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Lazertinib (JNJ-73841937) in Healthy Participants

**Official Title:** A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)

**NCT ID:** [NCT05076877](https://clinicaltrials.gov/study/NCT05076877)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Janssen Research & Development, LLC
- **Conditions:** Healthy
- **Start Date:** 2021-09-17
- **Completion Date:** 2022-02-10
- **CT.gov Last Update:** 2022-06-27

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy on the basis of medical history at screening only, and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study center
* Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study center.
* A woman who is considered surgically sterile but not postmenopausal, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Study Day 1. (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)
* Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator
* Non-smoker or not using tobacco containing products for at least 6 months before first study drug administration and test negative for cotinine at screening and Study Day 1

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor is considered cured with minimal risk of recurrence)
* History of suspected or confirmed coronavirus disease 2019 within 4 weeks before intake of study drug, or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at admission to the study site
* Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or probe substrates
* Taken any disallowed therapies, concomitant therapy before the planned first dose of study drug
* Had major surgery, (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study drug administration
```

## Arms

- **Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin** (EXPERIMENTAL) — Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.

## Interventions

- **Lazertinib** (DRUG) — Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
- **Midazolam** (DRUG) — Midazolam (cytochrome P450 3A4 \[CYP3A4\] substrate) will be administered orally as a syrup as a part of probe substrates.
- **Rosuvastatin** (DRUG) — Rosuvastatin (breast cancer resistant protein \[BCRP\] substrate) tablet will be administered orally as a part of probe substrates.
- **Metformin** (DRUG) — Metformin (organic cation transporter 1 \[OCT1\] substrate) will be administered orally as a syrup as a part of probe substrates.

## Primary Outcomes

- **Plasma Concentration of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) Co-administered with Lazertinib (Day 13) as Test Versus Plasma Concentration of Probe Substrates Administered Alone (Day 1) as Reference** _(time frame: Predose up to 12 hours postdose (Days 1 and 13))_ — 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.

## Secondary Outcomes

- **Number of Participants with Adverse Events (AEs)** _(time frame: Up to 56 days)_
- **Number of Participants with AEs by Severity** _(time frame: Up to 56 days)_
- **Number of Participants with Clinically Significant Changes in Laboratory Test Results** _(time frame: Up to 28 days)_
- **Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)** _(time frame: Up to 28 days)_
- **Number of Participants with Clinically Significant Abnormalities in Vital Signs** _(time frame: Up to 28 days)_
- **Number of Participants with Clinically Significant Abnormalities in Physical Examination** _(time frame: Up to 28 days)_
- **Plasma Concentrations of Lazertinib at steady-state** _(time frame: Predose on Day 7, 9, 11, 13, and 14)_
- **Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days** _(time frame: Day 14, 15, 16, 17, 21, and 28)_

## Locations (1)

- PRA Health Sciences, Salt Lake City, Utah, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pra health sciences|salt lake city|utah|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05076877*  
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