Clinical trial NCT02256774: Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects
Official title: Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

1. Males or females who meet the inclusion/exclusion criteria, females are not pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
2. Age ≥18 and \<60 years
3. Body Mass Index (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 and the local regulations

Exclusion Criteria:

1. Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Currently active (symptomatic within the last 30 days) 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. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
7. Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
8. Participation in another trial with an investigational drug within one month prior to administration or during the trial
9. Current smoker
10. Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
11. Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
12. Excessive physical activities (within 1 week prior to study drug administration or during the trial)
13. Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
14. Inability to comply with dietary regimen required by the protocol
15. Chronic or relevant acute infections
16. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
17. HIV-1 infected as defined by a positive HIV ELISA test

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state (AUC0-12h,ss)
timeFrame: up to day 18
measure: Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
timeFrame: up to day 18
Secondary outcomes:
measure: Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
timeFrame: up to day 18
measure: Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
timeFrame: up to day 18
measure: Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
timeFrame: up to day 18
measure: Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss)
timeFrame: up to day 18
measure: Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss)
timeFrame: up to day 18
measure: Number of subjects with adverse events
timeFrame: up to 49 days
measure: Number of subjects with abnormal laboratory parameters
timeFrame: up to 49 days
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 49 days
Other outcomes:
Locations:
Study officials:
References: