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: October 31, 2013
Last verified: October 2013

June 8, 2011
October 31, 2013
June 2011
July 2011   (final data collection date for primary outcome measure)
  • AUCt,ss of darunavir (DRV/r alone) [ Time Frame: day 8 ] [ Designated as safety issue: No ]
  • Ct, ss of darunavir (DRV/r alone) [ Time Frame: day 8 ] [ Designated as safety issue: No ]
  • Cmax, ss of darunavir (DRV/r alone) [ Time Frame: day 8 ] [ Designated as safety issue: No ]
  • AUCt, ss of darunavir (DRV/r with BI 201335) [ Time Frame: day 16 ] [ Designated as safety issue: No ]
  • Ct, ss of darunavir (DRV/r with BI 201335) [ Time Frame: day 16 ] [ Designated as safety issue: No ]
  • Cmax, ss of darunavir (DRV/r with BI 201335) [ Time Frame: day 16 ] [ Designated as safety issue: No ]
  • AUCt,ss on day 8 (DRV/r alone) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Ct, ss on day 8 (DRV/r alone) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Cmax, ss on day 8 (DRV/r alone) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • AUCt, ss on day 16 (DRV/r with BI 201335) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Ct, ss on day 16 (DRV/r with BI 201335) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Cmax, ss on day 16 (DRV/r with BI 201335) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01374802 on ClinicalTrials.gov Archive Site
  • Darunavir: tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state; DRV/r alone) [ Time Frame: day 8 ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (haematology) [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by the investigator (the investigator will assess tolerability at the end of treatment A and B according to the categories "good", "satisfactory", "not satisfactory", and "bad") [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (clinical chemistry) [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (urinalysis) [ Time Frame: 7.5 weeks ] [ Designated as safety issue: No ]
  • Darunavir: tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state; DRV/r with BI 201335) [ Time Frame: day 16 ] [ Designated as safety issue: No ]
  • Darunavir: tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (haematology) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by the investigator (the investigator will assess tolerability at the end of treatment A and B according to the categories "good", "satisfactory", "not satisfactory", and "bad") [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (clinical chemistry) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (urinalysis) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Darunavir
    400 mg tablet for oral administration
  • Drug: Ritonavir
    tablet for oral administration
  • Drug: BI 201335
  • Experimental: BI 201335
    capsule for oral administration
    Intervention: Drug: BI 201335
  • Experimental: Darunavir 400 mg
    tablet for oral administration
    Intervention: Drug: Darunavir
  • Experimental: Ritonavir 100 mg
    tablet for oral administration
    Intervention: Drug: Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests
  2. Age 18 to 55 years (incl.)
  3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

  1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. History of photosensitivity or recurrent rash.
  5. Surgery of the gastrointestinal tract (except appendectomy)
  6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  7. History of relevant orthostatic hypotension, fainting spells or blackouts.
  8. Chronic or relevant acute infections
  9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  10. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  12. Smoker (more than 10 cigarettes)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 30 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of trial site
  19. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
  20. Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus
  21. Vulnerable subjects (e.g. persons kept in detention)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01374802
1220.49, 2011-000505-41
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP