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

NCT05224609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lorlatinib

Single 100mg oral dose anti-cancer agent

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2024-08-13
Completion
2024-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05224609 on ClinicalTrials.gov