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Trial record 26 of 28 for:    RNA | BI 201335 OR faldaprevir

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT01374802
Recruitment Status : Completed
First Posted : June 16, 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
Interventions Drug: Darunavir
Drug: Ritonavir
Drug: BI 201335
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description

The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).

Period 2: Faldaprevir together with DRV/r.

Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title All Subjects
Hide Arm/Group Description

The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).

Period 2: faldaprevir together with DRV/r.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
40.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
2
  14.3%
Male
12
  85.7%
1.Primary Outcome
Title AUCτ,ss of Darunavir
Hide Description

area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.

The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities

Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
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Hide Analysis Population Description
Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.
Arm/Group Title Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Hide Arm/Group Description:
oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
57200
(29.5%)
66000
(39.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Darunavir+Ritonavir, Faldaprevir+Darunavir+Ritonavir
Comments relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir
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 115.29
Confidence Interval (2-Sided) 90%
101.36 to 131.13
Parameter Dispersion
Type: Standard Deviation
Value: 19.4
Estimation Comments the standard deviation is actually the geometric coefficient of variation
2.Primary Outcome
Title Cτ,ss of Darunavir
Hide Description concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Hide Arm/Group Description:
oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1330
(49.5%)
1170
(90.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Darunavir+Ritonavir, Faldaprevir+Darunavir+Ritonavir
Comments relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir
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 87.91
Confidence Interval (2-Sided) 90%
68.609 to 112.630
Parameter Dispersion
Type: Standard Deviation
Value: 38.3
Estimation Comments the standard deviation is actually the geometric coefficient of variation
3.Primary Outcome
Title Cmax,ss of Darunavir
Hide Description maximum measured concentration of the analyte in plasma at steady-state
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Hide Arm/Group Description:
oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
4930
(23.9%)
6330
(26.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Darunavir+Ritonavir, Faldaprevir+Darunavir+Ritonavir
Comments relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir
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 128.41
Confidence Interval (2-Sided) 90%
115.724 to 142.489
Parameter Dispersion
Type: Standard Deviation
Value: 15.6
Estimation Comments the standard deviation is actually the geometric coefficient of variation
4.Secondary Outcome
Title Tmax,ss of Darunavir
Hide Description time from last dosing to maximum concentration of the analyte in plasma at steady state
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Hide Arm/Group Description:
oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: h
1.50
(1.00 to 3.00)
2.01
(1.00 to 4.00)
Time Frame Adverse events (AEs) occurring up to 9 days after first drug administration of DRV/r were assigned to the treatment DRV/r and AEs occurring up to 13 days after last drug administration of DRV/r+FDV were assigned to the combined treatment DRV/r+FDV.
Adverse Event Reporting Description The subjects were required to spontaneously report any AEs. In addition, subjects were assessed regularly for AEs during the trial.
 
Arm/Group Title Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Hide Arm/Group Description oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
All-Cause Mortality
Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Darunavir+Ritonavir Faldaprevir+Darunavir+Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   7/14 (50.00%)   11/14 (78.57%) 
Eye disorders     
Eye haemorrhage  1  1/14 (7.14%)  0/14 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/14 (7.14%)  6/14 (42.86%) 
Abdominal distension  1  0/14 (0.00%)  4/14 (28.57%) 
Nausea  1  1/14 (7.14%)  2/14 (14.29%) 
Flatulence  1  1/14 (7.14%)  0/14 (0.00%) 
Vomiting  1  0/14 (0.00%)  1/14 (7.14%) 
General disorders     
Fatigue  1  3/14 (21.43%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/14 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
Headache  1  2/14 (14.29%)  3/14 (21.43%) 
Dizziness  1  1/14 (7.14%)  0/14 (0.00%) 
Somnolence  1  1/14 (7.14%)  0/14 (0.00%) 
Psychiatric disorders     
Insomnia  1  0/14 (0.00%)  1/14 (7.14%) 
Nervousness  1  0/14 (0.00%)  1/14 (7.14%) 
Sleep disorder  1  1/14 (7.14%)  0/14 (0.00%) 
Vascular disorders     
Hot flush  1  1/14 (7.14%)  0/14 (0.00%) 
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
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: NCT01374802     History of Changes
Other Study ID Numbers: 1220.49
2011-000505-41 ( EudraCT Number: EudraCT )
First Submitted: June 8, 2011
First Posted: June 16, 2011
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015