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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03174795
• Date of registration: 31/05/2017
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
• Scientific 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
• Date of first enrolment: July 11, 2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03174795
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Hungary, Latvia, Poland, Serbia, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Tract Infections

Intervention(s)

Drug: RO7079901

Drug: Meropenem

Primary Outcome(s)

Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901 [Time Frame: 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]

Fraction Excreted into the Urine (Fe) of RO7079901 [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

Maximum Observed Plasma Concentration (Cmax) of RO7079901 [Time Frame: 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]

Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901 [Time Frame: 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]

Steady State Volume of Distribution (Vss) of RO7079901 [Time Frame: 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]

Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901 [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

Total Clearance (CL) of RO7079901 [Time Frame: 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]

Renal Clearance (CLr) of RO7079901 [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

Secondary Outcome(s)

Vss of Meropenem [Time Frame: 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]

CL of Meropenem [Time Frame: 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]

CLr of Meropenem [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

AUC0-tau of Meropenem [Time Frame: 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]

Cmax of Meropenem [Time Frame: 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]

Fe of Meropenem [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

Tmax of Meropenem [Time Frame: 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]

Ae of Meropenem [Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)]

Secondary ID(s)

NP39596

2016-004478-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors