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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Darunavir
Drug: Ritonavir
Drug: BI 201335
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: June 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 201335
capsule for oral administration
Drug: BI 201335
Experimental: Darunavir 400 mg
tablet for oral administration
Drug: Darunavir
400 mg tablet for oral administration
Experimental: Ritonavir 100 mg
tablet for oral administration
Drug: Ritonavir
tablet for oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374802

Locations
Germany
1220.49.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

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
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014