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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
4,580 Previous Clinical Trials
14,634,181 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,811,056 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
~2 spots leftby Aug 2024
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