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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Prism Clinical Research
Saint Paul, Minnesota, United States
Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG])
Time frame: 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])
Time frame: 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])
Time frame: 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])
Time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline up to end of the study (up to approximately 7 months)