Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis

NCT01909778 ↗

Phase 1 Completed 2 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

Summary

This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (\< 7 points).

Timeline

Start: 2008-06
Primary completion: 2008-10
Completion: 2008-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faldaprevir	Small molecule	120 mg	Oral
Subject	Faldaprevir	Small molecule	240 mg	Oral

Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis

Summary

Timeline

Drugs

Indications