Healthy
Conditions
Brief summary
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
Interventions
DRUGBILR 355 - Treatment A (current tablet formulation)
DRUGBILR 355 - Treatment B (new tablet formulation)
DRUGBILR 355 - Treatment C (new capsule formulation)
DRUGBILR 355 - Treatment D (current tablet formulation)
DRUGBILR 355 - Treatment E (new capsule formulation)
DRUGRitonavir
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy HIV negative adult male volunteers 2. Age ≥18 and ≤60 years 3. BMI ≥18.5 and BMI ≤29.9 kg/m2 4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations
Exclusion criteria
1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 2. Surgery of gastrointestinal tract (except appendectomy) 3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 4. History of relevant orthostatic hypotension, fainting spells or blackouts 5. Chronic or relevant acute infections 6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator 7. Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial 8. Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial 9. Participation in another trial with an investigational drug within two months prior to administration or during the trial 10. Current smoker 11. Alcohol abuse (more than 60 g/day) 12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse) 13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial) 14. Excessive physical activities (within one week prior to study drug administration or during the trial) 15. Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator 16. Inability to comply with dietary regimen required by the protocol 17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 96 hours after drug administration |
| Cmax (maximum measured concentration of analyte in plasma) | up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 (terminal half-life of the analyte in plasma) | up to 96 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 96 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 96 hours after drug administration |
| Number of subjects with abnormal changes in laboratory parameters | up to 48 hours after drug administration |
| Number of subjects with adverse events | up to 12 days following last drug administration |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 96 hours after drug administration |
Outcome results
None listed