NCT03174795

A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

A Non-Randomized, Open-Label, One Treatment, One Group Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Patients With a Complicated Urinary Tract Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with meropenem.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	RO7079901	Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.
DRUG	Meropenem	Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-12-04
• Completion: 2017-12-16
• First posted: 2017-06-05
• Last updated: 2018-05-15

Locations

14 sites across 5 countries: United States, Hungary, Latvia, Poland, Serbia

Regulatory

• FDA-regulated drug study