Clinical trial NCT02214901: Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers
Official title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses BIBW 2948 BS (0.75 to 150 mg Inhalation Powder, Hard Capsule for HandiHaler®) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 91
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: Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS


Eligibility criteria: Inclusion Criteria:

* Healthy males based on a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:

  * No finding deviating from normal and of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Aged between ≥21 and ≤50 years
* BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2
* Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion Criteria:

* Any finding during the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* 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 relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre

Primary outcomes:
measure: Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature)
timeFrame: Up to 8 days after start of treatment
measure: Changes from baseline in clinical laboratory tests
timeFrame: Up to 8 days after start of treatment
measure: Changes from baseline in 12-lead electrocardiogram (ECG)
timeFrame: Up to 8 days after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to day 29
measure: Changes from baseline in airway resistance (Raw)
timeFrame: Pre-dose, up to 24 hours after start of treatment
measure: Assessment of tolerability by investigator, a 4-point scale
timeFrame: Up to 8 days after start of treatment
Secondary outcomes:
measure: Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Maximum concentration of BIBW 3056 ZW in plasma (Cmax)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Time from dosing to maximum concentration of the analytes in plasma (tmax)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Renal clearance of BIBW 3056 ZW from 0 to 24 hours (CLR,0-24)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Terminal rate constant of BIBW 3056 ZW in plasma (λz)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Terminal half life of BIBW 3056 ZW in plasma (t½)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Mean residence time of BIBW 3056 ZW in the body after inhalation (MRTih)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Apparent clearance of BIBW 3056 ZW in the plasma after extravascular administration (CL/F)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Apparent volume of distribution of BIBW 3056 ZW during the terminal phase λz following an extravascular dose (Vz/F)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
timeFrame: Pre-dose, up to 48 hours after start of treatment
Other outcomes:
Locations:
Study officials:
References: