Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004478-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7079901 and Meropenem | Experimental | Participants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7079901 | Drug | Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Renal Clearance (CLr) of RO7079901 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eStudySite | La Mesa | California | 91942 | United States | ||
| Jacksonville Center For Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Meropenem | Drug | Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days. |
|
| 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 | Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected) |
| 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 |
| Ae of Meropenem | Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected) |
| Fe of Meropenem | Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected) |
| 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 |
| 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 |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Semmelweis University, First Dept of Medicine | Budapest | 1083 | Hungary |
| Szent Imre Egyetemi Oktatokorhaz | Budapest | 1115 | Hungary |
| Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet | Debrecen | 4012 | Hungary |
| Liepaja Regional hospital | Liepāja | 3414 | Latvia |
| P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology | Riga | LV-1002 | Latvia |
| Riga East clinical university hospital | Riga | LV1006 | Latvia |
| Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology | Bydgoszcz | 85-094 | Poland |
| Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek | Lodz | 92-213 | Poland |
| Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii | Warsaw | 02-005 | Poland |
| Clinical Center of Serbia; Clinic of Urology | Belgrade | 11000 | Serbia |
| Clinical Center Zemun | Belgrade | 11080 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11080 | Serbia |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided