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NCT Number: NCT03174795

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Semmelweis University, First Dept of Medicine, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7079901

Drug

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

Meropenem

Drug

Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. 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)

  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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. CLr of Meropenem

    Time frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  4. 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

  5. Ae of Meropenem

    Time frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  6. Fe of Meropenem

    Time frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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