Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BILR 355 BS, D8Drug: BILR 355 BS, D5Drug: BILR 355 BS, D7Drug: BILR 355 BS, D1Drug: BILR 355 BS, D3Drug: BILR 355 BS, D4Drug: BILR 355 BS, D6Drug: BILR 355 BS, D2Drug: PlaceboDrug: BILR 355 BS, D10Other: high-fat breakfast
- Registration Number
- NCT02253953
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 62
Inclusion Criteria
- All participants in the study should be healthy males
- Age range from 21 to 50 years
- Body mass index (BMI) be within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion Criteria
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
Following exclusion criteria are of special interest for this study:
- Erythema, exanthema and comparable skin alterations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D2 Ritonavir - D8 BILR 355 BS, D8 - D3 Ritonavir - D5 BILR 355 BS, D5 - D7 BILR 355 BS, D7 - D1 BILR 355 BS, D1 - D3 BILR 355 BS, D3 - D4 BILR 355 BS, D4 - D6 BILR 355 BS, D6 - D1 Ritonavir - D2 BILR 355 BS, D2 - Placebo Placebo for D3 - D10 D10 BILR 355 BS, D10 - D10 high-fat breakfast - D10 Ritonavir - D5 Ritonavir - D4 Ritonavir - D6 Ritonavir - D7 Ritonavir - D8 Ritonavir - Placebo Ritonavir for D3 - D10
- Primary Outcome Measures
Name Time Method Maximum observed concentration of the analyte in plasma (Cmax) up to 120 hours after drug administration Terminal half-life of the analyte in plasma (t1/2) up to 120 hours after drug administration Time to reach Cmax (tmax) up to 120 hours after drug administration Total mean residence time (MRTtot) up to 120 hours after drug administration Urinary excretion (Ae) up to 72 hours after drug administration Area under the concentration-time curve (AUC) up to 120 hours after drug administration Total clearance of the analyte in plasma (CL/F) up to 120 hours after drug administration Renal clearance (CLR) up to 72 hours after drug administration Apparent volume of distribution (Vz/F) up to 120 hours after drug administration
- Secondary Outcome Measures
Name Time Method Number of subjects with adverse events up to 26 days