A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants

NCT05742594 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10931573841937NSC1009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib

  Cmax is defined as maximum observed plasma concentration.

  Pre dose up to 168 hours post dose

• Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib

  AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.

  Pre dose up to 168 hours post dose

Secondary Outcomes (9)

• Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib

  Pre dose up to 168 hours post dose

• Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib

  Pre dose up to 168 hours post dose

• Number of Participants With Adverse Events (AEs)

  Up to 14 weeks

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 14 weeks

• Number of Participants With AEs by Severity

  Up to 14 weeks

Study Arms (4)

Intervention Sequence: ADBC

EXPERIMENTAL

Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.

Drug: Lazertinib

Intervention Sequence: BACD

EXPERIMENTAL

Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.

Drug: Lazertinib

Intervention Sequence: CBDA

EXPERIMENTAL

Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.

Drug: Lazertinib

Intervention Sequence: DCAB

EXPERIMENTAL

Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.

Drug: Lazertinib

Interventions

Lazertinib DRUG

Lazertinib will be administered orally.

Also known as: JNJ-73841937

Intervention Sequence: ADBC; Intervention Sequence: BACD; Intervention Sequence: CBDA; Intervention Sequence: DCAB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site
• All female participants must have a negative highly sensitive serum Beta-human chorionic gonadotropin (Beta-HCG) at screening and on Day -1 of Intervention Period 1
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention
• Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Female participants must be postmenopausal or surgically sterile

You may not qualify if:

• History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs
• History of malignancy within 5 years before screening
• Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients
• Participant has a history of clinically significant allergies
• Had major surgery, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from the 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 intervention administration

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

lazertinib

Study Officials

• Janssen Research & Development, LLC Clinical Trail

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: January 3, 2023
• Primary Completion: March 31, 2023
• Study Completion: April 3, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)