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

Phase 1

Completed

• Conditions: Liver Cirrhosis; Hepatitis C
• Interventions: Drug: BI 201335

• Registration Number: NCT01909778
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Results First Submitted: 2015-07-03
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Results First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 201335	BI 201335	BI 201335 two single oral doses, separated by 14 days washout period

Primary Outcome Measures

Name	Time	Method
AUC 0-∞	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after drug administration on day 1 and day 15	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).
Cmax	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.

Secondary Outcome Measures

Name	Time	Method
AUC0-tz	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).
t1/2	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.
CL/F	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Apparent clearance of the analyte in plasma following extravascular administration (CL/F).; The apparent clearance after oral administration will be determined according to the following equation: CL or CL/F=dose/AUC0-∞. (F=absolute bioavailability factor)
Vz/F	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).
MRTpo	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Mean residence time of the analyte in the body after oral administration (MRTpo).
Assessment of Tolerability by Investigator	Day 6 of period 1 and 2	The investigator has assessed tolerability based on adverse events and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 1="good", 2="satisfactory", 3="not satisfactory", and 4="bad".
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG	from intake of the second dose Faldaprevir up to 9 days	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Tmax	-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15	Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.

Trial Locations

Locations (1)

1220.15.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany