Clinical trial NCT02268136: Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL
Official title: A Single-blind, Placebo-controlled, Parallel Group, Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIII 890 CL (Dosage: 0.5 mg/h - 80 mg/h), Infusion Time 1 Hour.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 76
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 ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Age ≥ 21 and ≤ 50 years
* Broca index ≥ - 20% and ≤ + 20%
* Signed written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Results of the medical examination, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system trauma in the medical history or with psychiatric disorders or neurological disorders
* Known 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 a drug with a long half-life (≥ 24 hours) within the last month or less than ten half-lives of the respective drug before enrolment in the study
* Intake of any other drugs 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
* Smokers (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who are not able to refrain from smoking on study days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Participation in excessive physical activities (e.g. competitive sports) within the last week before the study
* Blood donation (≥ 100 ml) within the last 4 weeks

Primary outcomes:
measure: Number of subjects with clinically relevant changes in vital signs
timeFrame: up to 8 days after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in electrocardiogram
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in pharmaco electroencephalogram (EEG)
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with clinically relevant changes in laboratory parameters
timeFrame: up to 8 days after drug administration
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 24 hours after drug administration
measure: Time to reach Cmax (tmax)
timeFrame: up to 24 hours after drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 24 hours after drug administration
measure: Area under the plasma concentration-time curve (AUC) for several time points
timeFrame: up to 24 hours after drug administration
measure: Mean residence time (MRT)
timeFrame: up to 24 hours after drug administration
measure: Plasma clearance (CL)
timeFrame: up to 24 hours after drug administration
measure: Volume of distribution (Vz)
timeFrame: up to 24 hours after drug administration
measure: Amount of the analyte excreted in urine (Ae)
timeFrame: up to 24 hours after drug administration
Other outcomes:
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