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Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

NCT03961997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-01-18

No results posted yet for this study

Summary

The primary purpose of the study is to characterize the safety profile of lorlatinib in the presence of a moderate CYP3A4/5 inducer, modafinil. In another drug-drug interaction study for lorlatinib coadministered with a strong CYP3A4/5 inducer, rifampin, all participants experienced increases in liver enzymes after receiving the combination of a single dose lorlatinib (100 mg) with rifampin (600 mg daily (QD)) after multiple doses of rifampin. The AST and ALT continued to increase over the next 24-48 hours, but recovered below the upper limit of normal for all participants upon discontinuation of rifampin.

We hypothesize the combination of lorlatinib with the moderate CYP3A inducer modafinil will not have a safety findings related to liver enzyme elevation similar to what occurred in the study with rifampin and lorlatinib.

Conditions

  • Adult
  • Drug Interactions
  • Healthy Volunteers
  • Humans

Interventions

DRUG

Lorlatinib 50 mg

Participants will receive a single dose of lorlatinib 50 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 50 mg on Day 15 of Period 2.

DRUG

Lorlatinib 75 mg

Participants will receive a single dose of lorlatinib 75 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 75 mg on Day 15 of Period 2.

DRUG

Lorlatinib 100 mg

Participants will receive a single dose of lorlatinib 100 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 100 mg on Day 15 of Period 2.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2019-12-09
Completion
2019-12-09
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961997 on ClinicalTrials.gov