NCT03534622

Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 steady-state intrapulmonary disposition of delafloxacin in healthy adult participants.

Detailed description

This study will evaluate the safety and pharmacokinetics (PK) of delafloxacin in healthy adult participants by assessing the intrapulmonary disposition in adults receiving 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Delafloxacin	In this study, thirty subjects who meet the entry criteria will be assigned to 1 of 5 groups (A, B,C, D, or E) to receive 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days

Timeline

• Start date: 2018-04-30
• Primary completion: 2018-07-19
• Completion: 2018-07-27
• First posted: 2018-05-23
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study