NCT03542305

Lorlatinib Renal Impairment Study

A PHASE 1, SINGLE DOSE OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF LORLATINIB IN SUBJECTS WITH IMPAIRED RENAL FUNCTION

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Lorlatinib	Lorlatinib single oral dose

Timeline

• Start date: 2018-08-23
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2018-05-31
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study