A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants

Healthy Clinical Trial

Official title:

A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410094
• Other study ID #: CR108799
• Secondary ID: 73841937NSC1003
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening

• Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)

• Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening

• Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening

• Male participants must agree to use an adequate contraception method

Exclusion Criteria:

• History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug

• Participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or to itraconazole and rifampin

• Participant has contraindications to the use itraconazole and rifampin per local prescribing information

• Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lazertinib
Lazertinib tablets will be administered orally.
• Itraconazole
Itraconazole capsules will be administered orally.
• Rifampin
Rifampin capsules will be administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib	Cmax is defined as maximum plasma concentration.	Predose up to 120 hours post dose
Primary	Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib	AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.	Predose up to 120 hours post dose
Primary	Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib	AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.	Predose up to 120 hours post dose
Primary	Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib	AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.	Predose up to 120 hours post dose
Primary	Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib	%AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.	Predose up to 120 hours post dose
Secondary	Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.	Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)