Clinical trial NCT02253953: Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers
Official title: An Open Study to Investigate the Effect of Two Times Oral 100 mg Ritonavir Capsules on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers, and a Double Blind, Placebo Controlled Study for Doses From 25 mg to 100 mg BILR 355 BS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 62
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed concentration of the analyte in plasma (Cmax)
timeFrame: up to 120 hours after drug administration
measure: Time to reach Cmax (tmax)
timeFrame: up to 120 hours after drug administration
measure: Area under the concentration-time curve (AUC)
timeFrame: up to 120 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: up to 120 hours after drug administration
measure: Total clearance of the analyte in plasma (CL/F)
timeFrame: up to 120 hours after drug administration
measure: Total mean residence time (MRTtot)
timeFrame: up to 120 hours after drug administration
measure: Apparent volume of distribution (Vz/F)
timeFrame: up to 120 hours after drug administration
measure: Renal clearance (CLR)
timeFrame: up to 72 hours after drug administration
measure: Urinary excretion (Ae)
timeFrame: up to 72 hours after drug administration
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 26 days
Other outcomes:
Locations:
Study officials:
References: