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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174795
• Other study ID #: NP39596
• Secondary ID: 2016-004478-16
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2017
• Est. completion date: December 16, 2017

Study information

• Verified date: May 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)

• Clinical signs and/or symptoms of pyelonephritis or a cUTI

• Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism

• Negative urine pregnancy test result confirmed by a blood test

• Agreement to remain abstinent or use a contraceptive method

Exclusion Criteria:

• Has a concomitant infection requiring antibacterial therapy, in addition to study drug

• Confirmed fungal urinary tract infection

• Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant

• Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy

• Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period

• Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry

• Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)

• Suspected or confirmed perinephric or intra renal abscess

• Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion

• History of epilepsy, brain lesions or other significant neurological disorders

• Use of probenecid within the 7 days before enrollment

• Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic

• Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study

• Women who are pregnant, planning to become pregnant, or lactating

• Participation in a clinical study of an investigational drug or device within one month prior to enrollment

• Prior enrollment in this study

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• RO7079901
Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.
• Meropenem
Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.

Locations

Country	Name	City	State
Hungary	Semmelweis University, First Dept of Medicine	Budapest
Hungary	Szent Imre Egyetemi Oktatokorhaz	Budapest
Hungary	Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet	Debrecen
Latvia	Liepaja Regional hospital	Liepaja
Latvia	P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology	Riga
Latvia	Riga East clinical university hospital	Riga
Poland	Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikolaja Kopernika w Toruniu; Urology	Bydgoszcz
Poland	Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek	Lódz
Poland	Szpital Kliniczny Dzieciatka Jezus; Oddzial Urologii	Warszawa
Serbia	Clinical Center of Serbia; Clinic of Urology	Belgrade
Serbia	Clinical Center Zemun	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	eStudySite	La Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Hungary,  Latvia,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Primary	Total Clearance (CL) of RO7079901		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Primary	Renal Clearance (CLr) of RO7079901		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Primary	Maximum Observed Plasma Concentration (Cmax) of RO7079901		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Primary	Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Primary	Fraction Excreted into the Urine (Fe) of RO7079901		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Primary	Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Primary	Steady State Volume of Distribution (Vss) of RO7079901		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Secondary	AUC0-tau of Meropenem		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Secondary	CL of Meropenem		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Secondary	CLr of Meropenem		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Secondary	Cmax of Meropenem		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Secondary	Ae of Meropenem		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Secondary	Fe of Meropenem		Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Secondary	Tmax of Meropenem		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Secondary	Vss of Meropenem		Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7