NCT02505997

Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects

A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.

Detailed description

This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.

Conditions

• VA Drug Interactions

Interventions

Type	Name	Description
DRUG	Midazolam	Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.
DRUG	Delafloxacin	Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-07-22
• Last updated: 2016-12-16

Locations

1 site across 1 country: United States