NCT03291158

Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV

A Phase 1, Randomized, Open-Label Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Minocin (Minocylcine) for Injection

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for injection in healthy adult subjects.

Detailed description

The purpose of this study is to evaluate the safety of Minocin IV and measure plasma, epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.

Conditions

• Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Minocycline	Subjects will be assigned into 5 cohorts of 5 subjects each, who will receive six doses of Minocin IV every 12 hours, starting on Day 1. Each dose of Minocin IV will be administered as an IV infusion over 1 hour. Subjects will be assigned to cohort based on time of bronchoalveolar lavage.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-09-25
• Last updated: 2023-09-21

Locations

1 site across 1 country: Austria