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This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Label: RO7079901 (Mild) (Part 1) | Experimental | Participants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901. |
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| RO7079901 (Moderate) (Part 1) | Experimental | Participants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901. |
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| RO7079901 (Severe) (Part 1) | Experimental | Participants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901. |
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| RO7079901 (Normal) (Part 1) | Active Comparator | Control group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901. |
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| RO7079901 (End-stage) (Part 2) | Experimental | Participants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7079901 | Drug | Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data | Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) | |
| Volume of Distribution of the Central Compartment (Vc) of RO7079901 Using Plasma Concentration Data | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) | |
| Total Volume of Distribution (Vz) of RO7079901 Using Plasma Concentration Data | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) | |
| Volume of Distribution at Steady-State (Vss) of RO7079901 Using Plasma Concentration Data | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) | |
| Renal Clearance (CLr) of RO7079901 | Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose ( infusion length: 0.5 hr) | |
| Part 2: Dialysis Clearance (CLd) of RO7079901 | Dialyzer input, output blood and dialyzer fluid: 1.5 hours postdose (start of hemodialysis); 2.5, 3.5, 4.5 hours postdose (end of hemodialysis) (infusion length: 0.5 hr) | |
| Measured Creatinine Clearance (mCLcr) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901 | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) | |
| Maximum Plasma Concentration (Cmax) of RO7079901 |
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Inclusion Criteria:
- Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body weight of at least 45 kilograms (kg)
Control group participants, Part 1 only:
Participants with renal impairment, Part 1 only:
Participants with end-stage renal disease in Part 2 only:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-LaRoche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42059789 | Derived | Morita J, Ishiwata K, Matsumoto S, Rodriguez I, Patel K, Attley G, Mallalieu NL, Bentley D. A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel beta-lactamase inhibitor nacubactam. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0011326. doi: 10.1128/aac.00113-26. Epub 2026 Apr 30. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1) |
| Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG]) | Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1) |
| Estimated Creatinine Clearance Using the Modified Jelliffe Formula (eCLcr[Jelliffe]) | Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1) |
| Estimated Glomerular Filtration Rate (eGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (eGFR[MDRD]) | Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1) |
| eGFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Formula (eGFR[CKD-EPI]) | Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1) |
| Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) |
| Time to Reach Cmax (tmax) of RO7079901 | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) |
| Terminal Elimination Half-life (t1/2) of RO7079901 | Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr) |
| Cumulative Amount Excreted in Urine (Ae) of RO7079901 | Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose (infusion length: 0.5 hr) |
| Fraction Excreted in Urine (Fe) of RO7079901 | Blood:Predose (-1 to 0hr), 0.5, 1, 1.5, 8, 12, 24 hr postdose(Parts 1 and 2); 2, 3, 4, 6 hr postdose(Part 1); 4.5 hr postdose(end of hemodialysis)(Part 2); Urine:0-4, 4-8, 8-12, 12-24 hr postdose(Part 1); 0-12 hr postdose(Part 2)(infusion length: 0.5 hr) |
| Percentage of Participants with Adverse Events (AEs) | Baseline up to end of the study (up to approximately 7 months) |
| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |