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Trial record 7 of 50 for:    BI 201335 OR faldaprevir

Drug Drug Interaction of BI 201335 and Tenofovir

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ClinicalTrials.gov Identifier: NCT01340196
Recruitment Status : Completed
First Posted : April 22, 2011
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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: tenofovir/BI 201335
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
Period Title: Treat. Period 1 (Tenofovir)
Started 16
Completed 16
Not Completed 0
Period Title: Treat. Period 2 (Tenofovir/Faldaprevir)
Started 16
Completed 16
Not Completed 0
Period Title: Treat. Period 3 (Faldaprevir)
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title All Participants
Hide Arm/Group Description tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
37  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
3
  18.8%
Male
13
  81.3%
1.Primary Outcome
Title Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
Hide Description Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Time Frame 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 16 16 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
2700
(0.00% to 0.00%)
3290
(0.00% to 0.00%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir, Tenofovir/Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 121.89
Confidence Interval (2-Sided) 90%
111.714 to 132.999
Parameter Dispersion
Type: Standard Deviation
Value: 14.1
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
2.Primary Outcome
Title Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Hide Description Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Time Frame 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 16 16 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
300
(27.3%)
284
(16.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir, Tenofovir/Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 94.72
Confidence Interval (2-Sided) 90%
85.215 to 105.290
Parameter Dispersion
Type: Standard Deviation
Value: 17.2
Estimation Comments The standard deviation is actually the intra-individual gCV.
3.Primary Outcome
Title Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Hide Description Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Time Frame 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 16 16 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
54.0
(26.7%)
79.4
(21.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir, Tenofovir/Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 147.12
Confidence Interval 90%
134.482 to 160.943
Parameter Dispersion
Type: Standard Deviation
Value: 14.6
Estimation Comments The standard deviation is actually the intra-individual gCV.
4.Primary Outcome
Title Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
Hide Description Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
Time Frame 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 0 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
418000
(69.3%)
523000
(101%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir/Faldaprevir, Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 77.88
Confidence Interval (2-Sided) 90%
71.24 to 85.15
Parameter Dispersion
Type: Standard Deviation
Value: 13.4
Estimation Comments The standard deviation is actually the intra-individual gCV.
5.Primary Outcome
Title Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Hide Description Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Time Frame 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 0 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
41700
(51.4%)
50400
(91.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir/Faldaprevir, Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 81.73
Confidence Interval (2-Sided) 90%
71.56 to 93.34
Parameter Dispersion
Type: Standard Deviation
Value: 20.1
Estimation Comments The standard deviation is actually the intra-individual gCV.
6.Primary Outcome
Title Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Hide Description Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
Time Frame 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 0 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
31000
(79.5%)
40000
(113%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir/Faldaprevir, Faldaprevir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments No formal testing. Investigation of relative bioavailability.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 75.27
Confidence Interval (2-Sided) 90%
68.71 to 82.45
Parameter Dispersion
Type: Standard Deviation
Value: 13.7
Estimation Comments The standard deviation is actually the intra-individual gCV.
7.Secondary Outcome
Title Number of Patients With Drug Related Adverse Events During the Trial
Hide Description Outcome data are the numbers of subjects with investigator defined drug-related AEs
Time Frame From drug administration up to 32 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Unit of Measure: participants
0 15 9
8.Secondary Outcome
Title Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
Hide Description

Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Preferred term of relevant AE: Presyncope

Time Frame From drug administration up to 32 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description:
tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Unit of Measure: participants
1 0 0
Time Frame From drug administration up to 32 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tenofovir Tenofovir/Faldaprevir Faldaprevir
Hide Arm/Group Description tenofovir medium dose (300mg) once daily (qd) (day 1 to 7) tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15 Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
All-Cause Mortality
Tenofovir Tenofovir/Faldaprevir Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir Tenofovir/Faldaprevir Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir Tenofovir/Faldaprevir Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/16 (6.25%)   16/16 (100.00%)   10/16 (62.50%) 
Ear and labyrinth disorders       
Tinnitus  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Eye disorders       
Ocular icterus  1  0/16 (0.00%)  3/16 (18.75%)  2/16 (12.50%) 
Gastrointestinal disorders       
Diarrhoea  1  0/16 (0.00%)  7/16 (43.75%)  1/16 (6.25%) 
Nausea  1  0/16 (0.00%)  6/16 (37.50%)  0/16 (0.00%) 
Vomiting  1  0/16 (0.00%)  4/16 (25.00%)  1/16 (6.25%) 
Abdominal pain upper  1  0/16 (0.00%)  2/16 (12.50%)  1/16 (6.25%) 
Eructation  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Toothache  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
General disorders       
Malaise  1  0/16 (0.00%)  2/16 (12.50%)  1/16 (6.25%) 
Pain  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Hepatobiliary disorders       
Jaundice  1  0/16 (0.00%)  3/16 (18.75%)  2/16 (12.50%) 
Infections and infestations       
Oral herpes  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/16 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/16 (0.00%)  4/16 (25.00%)  3/16 (18.75%) 
Arthralgia  1  0/16 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
Musculoskeletal stiffness  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Nervous system disorders       
Headache  1  0/16 (0.00%)  10/16 (62.50%)  0/16 (0.00%) 
Dizziness  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Presyncope  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%) 
Tremor  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Sinus congestion  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Rash  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.0
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01340196     History of Changes
Other Study ID Numbers: 1220.50
First Submitted: April 20, 2011
First Posted: April 22, 2011
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015