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Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02273401
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate safety, tolerability, and pharmacokinetics of BI 11054

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 11054 CL Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 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 Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (0.5 μg to 70 μg Administered With the Respimat®) of BI 11054 CL in Healthy Male Volunteers
Study Start Date : January 2008
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: BI 11054 CL Drug: BI 11054 CL
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of subjects with clinically significant findings in physical examination [ Time Frame: up to 18 days after drug administration ]
  2. Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 18 days after drug administration ]
    blood pressure (BP), pulse rate (PR), respiratory rate (RR)

  3. Number of subjects with clinically significant findings in orthostasis tests [ Time Frame: up to 24 hours after drug administration ]
  4. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 18 days after drug administration ]
  5. Number of subjects with clinically significant findings in additional safety laboratory tests [ Time Frame: up to 24 hours after drug administration ]
    cyclic adenosine monophosphate (cAMP) and potassium

  6. Number of subjects with clinically significant changes in body temperature [ Time Frame: up to 24 hours after drug administration ]
  7. Number of subjects with clinically significant findings in electrocardiogram (ECG) [ Time Frame: up to 18 days after drug administration ]
  8. Number of subjects with adverse events [ Time Frame: up to 18 days after drug administration ]
  9. Number of subjects with findings of oropharyngeal inspection [ Time Frame: up to 24 hours after drug administration ]
  10. Number of subjects with findings of pulmonary auscultation [ Time Frame: up to 24 hours after drug administration ]
  11. Airway resistance (Raw) [ Time Frame: up to 24 hours after drug administration ]
    measured by body plethysmography

  12. Global tolerability assessed by investigator on a 4-point scale [ Time Frame: up to 18 days after drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 96 hours ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 96 hours ]
  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration) [ Time Frame: up to 96 hours ]
  4. AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2) [ Time Frame: up to 96 hours ]
  5. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 96 hours ]
  6. %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation) [ Time Frame: up to 96 hours ]
  7. λz (terminal rate constant in plasma) [ Time Frame: up to 96 hours ]
  8. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 96 hours ]
  9. MRTih (mean residence time of the analyte in the body after inhalation) [ Time Frame: up to 96 hours ]
  10. CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 96 hours ]
  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 96 hours ]
  12. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 96 hours ]
  13. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 96 hours ]
  14. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 96 hours ]


Information from the National Library of Medicine

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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 male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
  • Age ≥21 and ≤50 years
  • Body mass index (BMI) ≥18.5 and <30 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
  • 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) as judged clinically relevant by the investigator
  • Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
  • 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 randomisation
  • Participation in another trial with an investigational drug within 2 months prior to randomisation
  • Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  • Inability to refrain from smoking on trial days as judged by the investigator
  • Alcohol abuse (more than 40 g alcohol a day)
  • Drug abuse
  • Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
  • Excessive physical activities within 1 week prior to randomisation or during the trial
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of the study centre

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

  • Asthma or history of pulmonary hyperreactivity
  • Hyperthyrosis
  • Allergic rhinitis in need of treatment
  • Clinically relevant cardiac arrhythmia
  • Paroxysmal tachycardia (>100 beats per minute)

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273401     History of Changes
Other Study ID Numbers: 1250.1
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014