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

NCT02808052 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-09-04

Study results available
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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.

Conditions

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

Interventions

DRUG

Minocin (minocycline) for Injection

200mg IV Minocin given over 1 hour

Sponsors & Collaborators

  • Universitätsklinikum Köln

    collaborator OTHER

  • Innovative Medicines Initiative

    collaborator OTHER

  • Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

    lead INDUSTRY

Principal Investigators

  • Oliver Cornely, MD · Universitätsklinikum Köln

  • Volker Burst, MD, PD · Universitätsklinikum Köln

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2018-06-04
Completion
2018-06-04
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808052 on ClinicalTrials.gov