Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Darunavir; Ritonavir; BI 201335
Intervention description: 400 mg tablet for oral administration; tablet for oral administration
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility 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)