NCT03468777

A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lumicitabine	Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.
DRUG	Lansoprazole	Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.
DRUG	Ranitidine	Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Timeline

• Start date: 2018-03-06
• Primary completion: 2018-07-09
• Completion: 2018-07-09
• First posted: 2018-03-19
• Last updated: 2018-07-23

Locations

1 site across 1 country: Belgium