NCT02975388

A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901

A Multi-Center, Open-Label, Two-Part Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics of RO7079901

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	RO7079901	Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

Timeline

• Start date: 2016-12-20
• Primary completion: 2017-07-06
• Completion: 2017-07-06
• First posted: 2016-11-29
• Last updated: 2017-12-11

Locations

5 sites across 1 country: United States