Lorlatinib for Liver Dysfunction

Recruiting at3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Inclusion Criteria

My BMI is between 17.5 and 40, and I weigh more than 50 kg (110 lb).

Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol

I am willing and able to follow all study requirements.

Exclusion Criteria

I don't have conditions that could affect medication absorption, HIV, or risky health issues.

My kidney function, measured by eGFR, is above 60 mL/min/1.73 m2.

I haven't taken any prohibited medications in the last 12 days.

Treatment Details

Interventions

• Lorlatinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Cohort 3 Experimental Treatment 1 Intervention

Normal hepatic function

Group II: Cohort 2 Experimental Treatment 1 Intervention

Severe hepatic impairment group

Group III: Cohort 1 Experimental Treatment 1 Intervention

Moderate hepatic impairment group

Lorlatinib is already approved in Japan, Canada for the following indications:

Approved in Japan as Lorbrena for:

• Unresectable, advanced/recurrent non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement

Approved in Canada as Lorbrena for:

• Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University