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

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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

Brief Summary:
Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBW 2948 BS for oral inhalation Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : July 2005

Arm Intervention/treatment
Experimental: BIBW 2948 BS in single rising doses Drug: BIBW 2948 BS for oral inhalation
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. 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 ]
  2. Changes from baseline in clinical laboratory tests [ Time Frame: Up to 8 days after start of treatment ]
  3. Changes from baseline in 12-lead electrocardiogram (ECG) [ Time Frame: Up to 8 days after start of treatment ]
  4. Number of patients with adverse events [ Time Frame: Up to day 29 ]
  5. Changes from baseline in airway resistance (Raw) [ Time Frame: Pre-dose, up to 24 hours after start of treatment ]
    measured via plethysmography

  6. Assessment of tolerability by investigator, a 4-point scale [ Time Frame: Up to 8 days after start of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Maximum concentration of BIBW 3056 ZW in plasma (Cmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  3. Time from dosing to maximum concentration of the analytes in plasma (tmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Terminal rate constant of BIBW 3056 ZW in plasma (λz) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  8. Terminal half life of BIBW 3056 ZW in plasma (t½) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02214901    
Other Study ID Numbers: 1219.1
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014