Clinical trial NCT02222961: Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers
Official title: A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 60
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: The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Age 21 to 50 years
* Broca index from -20% to +20%
* Written informed consent prior to admission to the study

Exclusion Criteria:

* Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug 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
* Intake of any other drug which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Alcohol use of more than 60 g per day
* Drug dependency
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Blood donation within the last 4 weeks (\>= 100 ml)

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in ECG
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after drug administration
Secondary outcomes:
measure: Maximum concentration in plasma (Cmax)
timeFrame: up to 32 hours after first drug administration
measure: Time to maximum concentration in plasma (tmax)
timeFrame: up to 32 hours after first drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)
timeFrame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
timeFrame: up to 32 hours after first drug administration
measure: Total Mean residence time (MRTtot)
timeFrame: up to 32 hours after first drug administration
measure: Total plasma clearance (CLtot)
timeFrame: up to 32 hours after first drug administration
measure: Volume of distribution (Vz)
timeFrame: up to 32 hours after first drug administration
measure: Volume of distribution at steady state (Vss)
timeFrame: up to 32 hours after first drug administration
measure: Amount excreted into urine (Ae)
timeFrame: up to 32 hours after first drug administration
measure: Mean residence time of disposition (MRTdisp)
timeFrame: up to 32 hours after first drug administration
measure: Renal clearance (CLR)
timeFrame: up to 32 hours after first drug administration
Other outcomes:
Locations:
Study officials:
References: