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Tyrosine Kinase Inhibitor

Lorlatinib for Liver Dysfunction

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb)
Participants must be male or female of nonchildbearing potential of 18 to 75 years of age, inclusive, at the time of signing the ICD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post-dose
Awards & highlights

Study Summary

This trial will study how well lorlatinib works in patients with moderate or severe liver problems.

Who is the study for?
This trial is for adults aged 18-75 with liver dysfunction or healthy individuals matching certain criteria. Participants must have a BMI of 17.5 to 40 kg/m2 and weigh over 50 kg (110 lb). They should be able to follow the study plan and give informed consent. People with HIV, recent drug use, significant blood donations, or sensitivity to heparin are excluded.Check my eligibility
What is being tested?
The trial tests Lorlatinib's safety and effects in people with varying levels of liver function. Participants will take one dose orally and are grouped into cohorts based on their liver health: normal function, moderate impairment, or severe impairment.See study design
What are the potential side effects?
While specific side effects for Lorlatinib in this context aren't listed, common ones may include fatigue, vision issues, cognitive effects like confusion or mood changes, high cholesterol levels, and possible swelling due to fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 17.5 and 40, and I weigh more than 50 kg (110 lb).
Select...
I am between 18 and 75 years old and cannot become pregnant or get someone pregnant.
Select...
My liver function is moderately impaired but stable.
Select...
My liver function is severely impaired but stable.
Select...
I am healthy with normal liver function and no significant medical issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (inf)] of lorlatinib
Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)] of lorlatinib
Single dose Maximum Observed Plasma Concentration (Cmax) of lorlatinib
Secondary outcome measures
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of participants experienced serious adverse event assessed by investigator
+3 more

Side effects data

From 2020 Phase 1 trial • 29 Patients • NCT03542305
13%
Dizziness
13%
Headache
13%
Skin laceration
13%
Oropharyngeal pain
13%
Upper respiratory tract infection
13%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Function
Mild Impairment
Moderate Impairment
Severe Impairment

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Normal hepatic function
Group II: Cohort 2Experimental Treatment1 Intervention
Severe hepatic impairment group
Group III: Cohort 1Experimental Treatment1 Intervention
Moderate hepatic impairment group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
2018
Completed Phase 4
~440

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,418 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,532 Total Patients Enrolled

Media Library

Lorlatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05224609 — Phase 1
Healthy Subjects Research Study Groups: Cohort 2, Cohort 3, Cohort 1
Healthy Subjects Clinical Trial 2023: Lorlatinib Highlights & Side Effects. Trial Name: NCT05224609 — Phase 1
Lorlatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224609 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is the ideal candidate for participating in this trial?

"This trial seeks 24 individuals with significant hepatic impairment who are aged between 18 and 75 years. To qualify as a participant, you must meet the following criteria: Additional Inclusion Criteria for Participants with Normal Hepatic Function (Cohort 3) - Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including BP and pulse rate measurement, 12-lead ECG or clinical laboratory tests to confirm no known or suspected hepatic impairment based on liver function tests (eg ALT AST ALP bilirubin albumin prothrombin time). You also need to match specific demographics such as body weight"

Answered by AI

What is the anticipated result of this experiment?

"The primary goal of this clinical trial, evaluated over a slew of timepoints (0, 0.5, 1, etc.), is to calculate the Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (inf)] for lorlatinib. Secondary objectives include assessing any changes from baseline in QTcF and laboratory abnormalities deemed clinically significant by investigators as well as recording serious adverse events experienced by participants."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned Lorlatinib?

"With limited data confirming efficacy and safety, Lorlatinib is rated a 1 on our team's scale. This reflects that it is still at the Phase 1 trial stage."

Answered by AI

How many participants is the research team recruiting for this experiment?

"The study sponsor, Pfizer, is seeking 24 suitable candidates at two different locations: Genesis Clinical Research in Tampa, Florida and Prism Research LLC dba Nucleus Network in Saint Paul, Minnesota."

Answered by AI

Is this research experiment open to those aged 35 and above?

"Eligibility criteria requires that prospective participants must be above the age of consent and below 75 years old."

Answered by AI

Are there vacancies available in this clinical trial for participants?

"Affirmative. Clinicaltrials.gov furnishes evidence that this medical trial, initially posted on April 28th 2022, still requires participants; 24 individuals across 3 sites to be exact."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Orange County Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
2022. "A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224609.
All > Liver Disease
~3 spots leftby Aug 2024
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