At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 29 enrolled
Drug / intervention
Lorlatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1, SINGLE DOSE OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF LORLATINIB IN SUBJECTS WITH IMPAIRED RENAL FUNCTION
In Brief
A Phase 1 clinical trial evaluating Lorlatinib for Renal Impairment. Completed, enrolled 29 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartAug 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedMay 31, 2018
Enrollment StartAug 23, 2018
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.1 years ago
Interventions
Lorlatinibdrug
Lorlatinib single oral dose