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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
eStudySite
La Mesa, California, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Semmelweis University, First Dept of Medicine
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
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)
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
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)
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)
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
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Budapest, Hungary
Szent Imre Egyetemi Oktatokorhaz
Budapest, Hungary
Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet
Debrecen, Hungary
Liepaja Regional hospital
Liepāja, Latvia
P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology
Riga, Latvia
Riga East clinical university hospital
Riga, Latvia
Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology
Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
Lodz, Poland
...and 4 more locations
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
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)
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
Ae of Meropenem
Time frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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
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