NCT03441529

A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants

A Phase 1, Open-label, Randomized, 2-period, Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Subjects

• Status: Completed
• 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 this study is to evaluate the effect of intravenous (IV) infusions of piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose of lumicitabine in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lumicitabine	Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.
DRUG	Piperacillin/Tazobactam	Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.

Timeline

• Start date: 2018-02-09
• Primary completion: 2018-05-03
• Completion: 2018-05-03
• First posted: 2018-02-22
• Last updated: 2018-06-07

Locations

1 site across 1 country: Belgium