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Trial record 23 of 28 for:    RNA | BI 201335 OR faldaprevir

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

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ClinicalTrials.gov Identifier: NCT01909778
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
Liver Cirrhosis
Intervention Drug: BI 201335
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description

The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.

A number of 12 entered patients with compensated liver cirrhosis was planned.

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
failed screening             1
Arm/Group Title All Subjects
Hide Arm/Group Description

The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.

A number of 12 entered patients with compensated liver cirrhosis was planned.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
While a number of 12 entered patients with non-HCV liver cirrhosis was planned, only a total of 2 patients were enrolled in 1 centre in Germany.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
1.Primary Outcome
Title AUC 0-∞
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: h*ng/mL
7240 24700
2.Primary Outcome
Title Cmax
Hide Description Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: ng/mL
308 999
3.Secondary Outcome
Title Tmax
Hide Description Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: hours
8.00 8.00
4.Secondary Outcome
Title AUC0-tz
Hide Description Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: h*ng/mL
6770 23900
5.Secondary Outcome
Title t1/2
Hide Description Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: hours
33.8 26.8
6.Secondary Outcome
Title CL/F
Hide Description

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)

Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: mL/min
276 162
7.Secondary Outcome
Title Vz/F
Hide Description Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Liter
809 376
8.Secondary Outcome
Title MRTpo
Hide Description Mean residence time of the analyte in the body after oral administration (MRTpo).
Time Frame -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
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Mean (Standard Deviation)
Unit of Measure: hours
39.3 [1]   (NA) 31.6 [1]   (NA)
[1]
Not calculable as only one participant analysed.
9.Secondary Outcome
Title Assessment of Tolerability by Investigator
Hide Description 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”.
Time Frame Day 6 of period 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analysed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
1 1
10.Secondary Outcome
Title Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Hide Description 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.
Time Frame from intake of the second dose Faldaprevir up to 9 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was treated and completed this study; he was the only patient analyzed.
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description:
single dose of 120 mg Faldaprevir soft gel capsule.
single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame From intake of the second dose Faldaprevir up to 9 days. Patients were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events.
Adverse Event Reporting Description In addition, each patient was assessed by an investigator at any measurement time point as well as at the end of observation and whenever necessary as deemed by the investigator. Assessment was made using non-specific questions such as “How do you feel?”. Specific questions were asked wherever required or useful to more precisely describe an AE.
 
Arm/Group Title Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Hide Arm/Group Description single dose of 120 mg Faldaprevir soft gel capsule. single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
All-Cause Mortality
Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose of Faldaprevir (Period 1) High Dose of Faldaprevir (Period 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/1 (100.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/1 (100.00%)  1/1 (100.00%) 
Nausea  1  1/1 (100.00%)  1/1 (100.00%) 
Diarrhoea  1  1/1 (100.00%)  0/1 (0.00%) 
Soft stools  1  0/1 (0.00%)  1/1 (100.00%) 
General disorders     
Fatigue  1  1/1 (100.00%)  1/1 (100.00%) 
Nervous system disorders     
Disturbance in attention  1  0/1 (0.00%)  1/1 (100.00%) 
Skin and subcutaneous tissue disorders     
Sweating  1  0/1 (0.00%)  1/1 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01909778     History of Changes
Other Study ID Numbers: 1220.15
2007-007776-42 ( EudraCT Number: EudraCT )
First Submitted: July 25, 2013
First Posted: July 29, 2013
Results First Submitted: July 3, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015