Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

NCT05162274 | Completed Phase 1

• 1 other identifier: YH25448-102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.

Conditions

Healthy Adult Volunteers

Keywords

YH25448; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• AUClast of YH25448

  Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448

  0 - 168 hours

• Cmax of YH25448

  Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448

  0 - 168 hours

Secondary Outcomes (7)

• AUC0-72h of YH25448

  0 - 72 hours

• AUCinf of YH25448

  0 - 168 hours

• Tmax of YH25448

  0 - 168 hours

• t1/2 of YH25448

  0 - 168 hours

• λz of YH25448

  0 - 168 hours

Study Arms (2)

Group 1

EXPERIMENTAL

Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day.

Drug: Lazertinib(G001); Drug: Lazertinib(G002)

Group 2

EXPERIMENTAL

Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day.

Drug: Lazertinib(G001); Drug: Lazertinib(G002)

Interventions

Lazertinib(G001) DRUG

Current formulation

Group 1; Group 2

Lazertinib(G002) DRUG

New formulation

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, over 19 years of age
• Male participants must agree to use an adequate contraception method from the first to the third month after the last dose.
• Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg.
• Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis.
• Participants must be healthy on the basis of clinical laboratory tests performed at screening.
• Informed of the investigational nature of this study and voluntarily agree to participate in this study.

You may not qualify if:

• Clinically significant medical or psychiatric illness.
• Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg).
• A marked baseline prolongation of QTc.
• Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
• Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Development and Medical Department

  Yuhan Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: November 30, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: December 11, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)