RO7079901
DrugParticipants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
NCT Number: NCT02975388
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
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)
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 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 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 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)
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)
Time frame: Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)
Time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Time frame: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
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 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 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 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 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)
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)
Time frame: Baseline up to end of the study (up to approximately 7 months)
Hoffmann-La Roche
Industry
A Multi-Center, Open-Label, Two-Part Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics of RO7079901
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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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