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Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214901
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date August 13, 2014
Study Start Date  ICMJE March 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature) [ Time Frame: Up to 8 days after start of treatment ]
  • Changes from baseline in clinical laboratory tests [ Time Frame: Up to 8 days after start of treatment ]
  • Changes from baseline in 12-lead electrocardiogram (ECG) [ Time Frame: Up to 8 days after start of treatment ]
  • Number of patients with adverse events [ Time Frame: Up to day 29 ]
  • Changes from baseline in airway resistance (Raw) [ Time Frame: Pre-dose, up to 24 hours after start of treatment ]
    measured via plethysmography
  • Assessment of tolerability by investigator, a 4-point scale [ Time Frame: Up to 8 days after start of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Maximum concentration of BIBW 3056 ZW in plasma (Cmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Time from dosing to maximum concentration of the analytes in plasma (tmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Renal clearance of BIBW 3056 ZW from 0 to 24 hours (CLR,0-24) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Terminal rate constant of BIBW 3056 ZW in plasma (λz) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Terminal half life of BIBW 3056 ZW in plasma (t½) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Mean residence time of BIBW 3056 ZW in the body after inhalation (MRTih) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Apparent clearance of BIBW 3056 ZW in the plasma after extravascular administration (CL/F) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • Apparent volume of distribution of BIBW 3056 ZW during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  • The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers
Official Title  ICMJE 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
Brief Summary Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BIBW 2948 BS for oral inhalation
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BIBW 2948 BS in single rising doses
    Intervention: Drug: BIBW 2948 BS for oral inhalation
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2014)
91
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02214901
Other Study ID Numbers  ICMJE 1219.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP