Clinical trial NCT02198287: Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers
Official title: A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-23
Enrollment: 54
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: Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males, based on a complete medical examination
* Age range from 21 to 50 years
* Participant must be within +/- 20 % of their normal weight (Broca-Index)
* Participant must provide written informed consent

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests 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
* 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 at least one month or less than then half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to start of the study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse
* Drug abuse
* Blood donation (\> 100 ml) within four weeks prior to administration
* Other disease or abnormality of clinical relevance
* Excessive physical activities within two weeks prior to administration or during the trial

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 22 days
measure: Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
timeFrame: up to 8 days after drug administration
measure: Number of patients with clinically relevant changes in electrocardiogram (ECG)
timeFrame: up to 8 days after drug administration
measure: Number of patients with clinically relevant changes in impedance cardiography
timeFrame: pre-dose, 10 and 30 minutes after administration
measure: Number of patients with clinically relevant changes in cutaneous microcirculation
timeFrame: pre-dose, 10 and 30 minutes after administration
measure: Number of patients with clinically relevant changes in safety laboratory parameters
timeFrame: up to 8 days after drug administration
Secondary outcomes:
measure: Maximum concentration of the drug in plasma (Cmax)
timeFrame: up to 168 hours after drug administration
measure: Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)
timeFrame: up to 168 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: up to 168 hours after drug administration
measure: Clearance, divided by f (CL/f)
timeFrame: up to 168 hours after drug administration
Other outcomes:
Locations:
Study officials:
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