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Tyrosine Kinase Inhibitor

Lorlatinib for Liver Dysfunction

Phase 1
Waitlist Available
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
Must not have
Participants must not have any condition possibly affecting drug absorption, history of or current positive results for HIV infection, or other medical or psychiatric conditions that may increase the risk of study participation
Participants with an eGFR of ≤ 60 mL/min/1.73 m2 are excluded
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
No Placebo-Only Group

Summary

This trial tests Lorlatinib, a pill, in adults with different liver functions. Researchers will see how the medicine moves through the body and check for any side effects. Lorlatinib is approved for the treatment of a specific type of lung cancer.

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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have conditions that could affect medication absorption, HIV, or risky health issues.
Select...
My kidney function, measured by eGFR, is above 60 mL/min/1.73 m2.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
20%
Hyperglycaemia
20%
Dyspnoea
20%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Impairment
Mild Impairment
Moderate Impairment
Normal Function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~460

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
ALK and ROS1 inhibitors, such as Lorlatinib, work by targeting and blocking the activity of the ALK and ROS1 proteins, which are involved in the growth and survival of cancer cells. This mechanism is crucial for healthy subjects in clinical trials to ensure that the drug can effectively target cancer cells while minimizing adverse effects on normal cells. Studying these effects in healthy subjects helps establish the safety profile and optimal dosing of the drug before it is used in patients with cancer.
Safety profile of new anticancer drugs.Potential of interferon-alpha in solid tumours: part 2.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,640 Previous Clinical Trials
17,741,120 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,529 Previous Clinical Trials
14,913,253 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
~6 spots leftby Oct 2025