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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 54
- Primary Endpoint
- Number of patients with adverse events
Study Overview
Brief Summary
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BIIX 1 XX, rising doses
Intervention: BIIX 1 XX inhalation solution (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events
Time Frame: up to 22 days
Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
Time Frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in cutaneous microcirculation
Time Frame: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in safety laboratory parameters
Time Frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Time Frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in impedance cardiography
Time Frame: pre-dose, 10 and 30 minutes after administration
Secondary Outcomes
- Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)(up to 168 hours after drug administration)
- Maximum concentration of the drug in plasma (Cmax)(up to 168 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(up to 168 hours after drug administration)
- Clearance, divided by f (CL/f)(up to 168 hours after drug administration)