Lorlatinib Renal Impairment Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Lorlatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03542305

B7461010

RENAL IMPAIRMENT (Other Identifier)

Details and patient eligibility

About

This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.

Full description

This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment. Each subject will receive a single oral dose of lorlatinib administered in the fasted state. Subjects with mild, moderate, and severe renal impairment will be enrolled and normal healthy subjects will be enrolled as matched controls.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects of non-childbearing potential
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Demonstrate stable renal function

Exclusion criteria

• Renal allograft recipients
• Any condition possibly affecting drug absorption (eg, gastrectomy)
• A positive urine drug test
• History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
• Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec
• Second-degree or third-degree AV block (unless paced) or baseline PR interval >180 msec at any time prior to dosing of study treatment.
• Abnormalities in clinical laboratory tests at screening
• Pregnant or breastfeeding female subjects
• History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

Mild

Experimental group

Description:

Mild renal impairment

Treatment:

Drug: Lorlatinib

Moderate

Experimental group

Description:

Moderate renal impairment

Treatment:

Drug: Lorlatinib

Severe

Experimental group

Description:

Severe renal impairment

Treatment:

Drug: Lorlatinib

Normal

Other group

Description:

Normal renal function

Treatment:

Drug: Lorlatinib