A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction

Healthy Volunteers Clinical Trial

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF LORLATINIB IN PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Status Recruiting

Clinical Trial Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who:

• Must be male or female of 18 to 75 years of age, inclusive at the time of the study.

• Are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

• Have a BMI (body mass index) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb).

• Are capable of giving signed informed consent document. All participants in this study will receive Lorlatinib. Participants will be placed into 1 of 3 cohorts based on their hepatic (liver) function. Participants will take Lorlatinib once by mouth. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will take part in this study for up to 35 days.

Clinical Trial Description

This is a Phase 1, open label, parallel group study to investigate the effect of moderate and severe hepatic impairment on the plasma PK, safety, and tolerability after a single oral 100 mg dose of lorlatinib under fasted conditions. ;

Related Conditions & MeSH terms

• Healthy Volunteers
• Liver Diseases
• Moderate Hepatic Impairment
• Severe Hepatic Impairment

• NCT number: NCT05224609
• Study type: Interventional
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2022
• Completion date: August 31, 2024