NCT02808052

Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency

A Phase I, Open-Label, Single-Dose Trial To Determine The Safety And Pharmacokinetics Of Minocin (Minocycline) For Injection In Subjects With Renal Insufficiency

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.

Detailed description

The purpose of this study is to collect safety, tolerability, and pharmacokinetics (PK) data on a single dose of Minocin® (minocycline) for Injection in subjects with renal insufficiency and in subjects receiving hemodialysis therapy. The safety, tolerability, and PK data will support the compound as a potential clinical candidate in Europe and will inform the development of future Phase 2/3 studies.

Conditions

• Renal Insufficiency, Acute
• Renal Insufficiency, Chronic
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Minocin (minocycline) for Injection	200mg IV Minocin given over 1 hour

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-06-04
• Completion: 2018-06-04
• First posted: 2016-06-21
• Last updated: 2019-09-04
• Results posted: 2019-07-24

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study