NCT03961997View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 22, 2019

Primary Completion Date

December 9, 2019

Study Completion Date

December 9, 2019

Conditions
AdultDrug InteractionsHealthy VolunteersHumans
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.

Trial Locations (1)

B-1070

Brussels Clinical Research Unit, Brussels

Sponsors

Lead Sponsor

Pfizer
All Listed Sponsors
lead

Pfizer

INDUSTRY