NCT01957657

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	BI 207127	oral administration
DRUG	faldaprevir	oral administration
DRUG	BI 207127	oral administration
DRUG	BI 207127	oral administration
DRUG	BI 207127	oral administration
DRUG	faldaprevir	oral administration
DRUG	faldaprevir	oral administration
DRUG	faldaprevir	oral administration

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-08
• Last updated: 2016-04-11
• Results posted: 2016-04-11

Locations

1 site across 1 country: Germany