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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01374802
First received: June 8, 2011
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: BI 201335

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Subjects

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.


Participant Flow:   Overall Study
    All Subjects  
STARTED     14  
COMPLETED     14  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Reporting Groups
  Description
All Subjects

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.


Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Mean (Standard Deviation)
  40.4  (9.9)  
Gender  
[units: participants]
 
Female     2  
Male     12  



  Outcome Measures
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1.  Primary:   AUCτ,ss 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 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]

2.  Primary:   Cτ,ss 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) ]

3.  Primary:   Cmax,ss 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) ]

4.  Secondary:   Tmax,ss 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 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01374802     History of Changes
Other Study ID Numbers: 1220.49, 2011-000505-41
Study First Received: June 8, 2011
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices