Phase 1
N=29
Lorlatinib Renal Impairment Study
Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03542305 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib — 8329; 8683; 9890; 11760 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lorlatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib |
8329; 8683; 9890; 11760 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Lorlatinib |
546.8; 549.7; 485.9; 504.8 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
5; 2; 4; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities |
4; 2; 8; 5 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria |
0; 0; 0; 1; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03542305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.