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Trial record 24 of 28 for:    RNA | BI 201335 OR faldaprevir

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580306
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Intervention Drug: BI 201335
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Period Title: Overall Study
Started 8 8 8 8
Completed 8 8 8 8
Not Completed 0 0 0 0
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment Total
Hide Arm/Group Description

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
62.3  (2.1) 58.8  (9.3) 67.1  (7.5) 57.6  (9.5) 61.4  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
Female
2
  25.0%
3
  37.5%
3
  37.5%
3
  37.5%
11
  34.4%
Male
6
  75.0%
5
  62.5%
5
  62.5%
5
  62.5%
21
  65.6%
1.Primary Outcome
Title AUC0-∞
Hide Description

area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.

In this endpoint, the data of AUC0-∞ show inter-individual variabilities.

Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Overall Number of Participants Analyzed 5 4 7 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
76500
(95.7%)
86900
(89.8%)
136000
(67.2%)
129000
(98.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments relative bioavailability comparison mild : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 113.57
Confidence Interval (2-Sided) 90%
41.58 to 310.17
Parameter Dispersion
Type: Standard Deviation
Value: 93.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments relative bioavailability comparison moderate : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 178.31
Confidence Interval (2-Sided) 90%
85.23 to 373.03
Parameter Dispersion
Type: Standard Deviation
Value: 78.9
Estimation Comments the standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments relative bioavailability comparison severe : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 169.21
Confidence Interval (2-Sided) 90%
73.19 to 391.17
Parameter Dispersion
Type: Standard Deviation
Value: 97.7
Estimation Comments the standard deviation is actually the geometric coefficient of variation
2.Primary Outcome
Title Cmax
Hide Description maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Overall Number of Participants Analyzed 5 4 7 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
3810
(80.7%)
4080
(144.0%)
6680
(63.2%)
4600
(135.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments relative bioavailability comparison mild : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 107.22
Confidence Interval (2-Sided) 90%
35.16 to 327.01
Parameter Dispersion
Type: Standard Deviation
Value: 107.7
Estimation Comments the standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments relative bioavailability comparison moderate : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 175.52
Confidence Interval (2-Sided) 90%
89.55 to 344.06
Parameter Dispersion
Type: Standard Deviation
Value: 70.4
Estimation Comments the standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments relative bioavailability comparison severe : normal
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 120.98
Confidence Interval (2-Sided) 90%
47.257 to 309.736
Parameter Dispersion
Type: Standard Deviation
Value: 115
Estimation Comments the standard deviation is actually the geometric coefficient of variation
3.Secondary Outcome
Title Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Hide Description Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame from drug administration up to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
treated set
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Overall Number of Participants Analyzed 8 8 8 8
Measure Type: Number
Unit of Measure: participants
Blood bilirubin increased 0 0 0 1
blood pressure systolic increased 0 0 1 0
4.Secondary Outcome
Title Number of Participants With Drug Related Adverse Events
Hide Description number of participants with investigator-defined drug related adverse events.
Time Frame drug administration until end-of-study examination (7 to 14 days after drug administration)
Hide Outcome Measure Data
Hide Analysis Population Description
treated set
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Overall Number of Participants Analyzed 8 8 8 8
Measure Type: Number
Unit of Measure: participants
5 8 5 7
Time Frame From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing)
Adverse Event Reporting Description Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
 
Arm/Group Title BI 201335 Relevant Treatment Dose (Normal Renal Function) BI 201335 Relevant Treatment Dose (Mild Renal Impairment) BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) BI 201335 Relevant Treatment Dose (Severe Renal Impairment)
Hide Arm/Group Description

Capsule for oral administration

estimated glomerular filtration rate >= 90 mL/min/1.73m2

Capsule for oral administration

estimated glomerular filtration rate 60-89 mL/min/1.73m2

Capsule for oral administration

estimated glomerular filtration rate 30-59 mL/min/1.73m2

Capsule for oral administration

estimated glomerular filtration rate 15-29 mL/min/1.73m2

All-Cause Mortality
BI 201335 Relevant Treatment Dose (Normal Renal Function) BI 201335 Relevant Treatment Dose (Mild Renal Impairment) BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) BI 201335 Relevant Treatment Dose (Severe Renal Impairment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BI 201335 Relevant Treatment Dose (Normal Renal Function) BI 201335 Relevant Treatment Dose (Mild Renal Impairment) BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) BI 201335 Relevant Treatment Dose (Severe Renal Impairment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BI 201335 Relevant Treatment Dose (Normal Renal Function) BI 201335 Relevant Treatment Dose (Mild Renal Impairment) BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) BI 201335 Relevant Treatment Dose (Severe Renal Impairment)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   8/8 (100.00%)   5/8 (62.50%)   7/8 (87.50%) 
Gastrointestinal disorders         
Diarrhoea  1  3/8 (37.50%)  6/8 (75.00%)  5/8 (62.50%)  7/8 (87.50%) 
Gastrointestinal disorder  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
Nausea  1  1/8 (12.50%)  3/8 (37.50%)  1/8 (12.50%)  2/8 (25.00%) 
Vomiting  1  3/8 (37.50%)  4/8 (50.00%)  1/8 (12.50%)  0/8 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%) 
Investigations         
Blood bilirubin increased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Blood pressure systolic increased  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders         
Neck pain  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nervous system disorders         
Headache  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Syncope  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
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: NCT01580306     History of Changes
Other Study ID Numbers: 1220.58
2011-005442-35 ( EudraCT Number: EudraCT )
First Submitted: April 12, 2012
First Posted: April 19, 2012
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015