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

Phase 1 Completed 22 enrolled Melinta Therapeutics, Inc.

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2015-06
Primary completion: 2015-07
Completion: 2015-07

Publications

Paulson SK, Wood-Horrall RN, Hoover R, Quintas M, Lawrence LE, Cammarata SK. The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin. Clin Ther. 2017 Jun;39(6):1182-1190. doi: 10.1016/j.clinthera.2017.04.009. Epub 2017 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delafloxacin	Small molecule	450 mg	Oral
Subject	Midazolam	Small molecule	5 mg	Oral

Indications

No indication recorded.