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Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02254135
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BEA 2180 BR

Condition or disease Intervention/treatment Phase
Healthy Drug: BEA 2180 BR - rising dose Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Peroral Doses (400, 800, 1200 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers
Study Start Date : December 2006
Actual Primary Completion Date : January 2007

Arm Intervention/treatment
Experimental: BEA 2180 BR solution - rising dose Drug: BEA 2180 BR - rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of subjects with abnormal findings in physical examination [ Time Frame: up to 14 days after last procedure ]
  2. Number of subjects with clinically significant changes in vital signs [ Time Frame: up to 14 days after last procedure ]
    (Blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)

  3. Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 14 days after last procedure ]
  4. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 14 days after last procedure ]
  5. Number of subjects with adverse events [ Time Frame: up to 14 days after last procedure ]
  6. Assessment of tolerability by the investigator on a 4-point scale [ Time Frame: 14 days after last procedure ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 48 h after drug administration ]
  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 48 h after drug administration ]
  3. 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 48 h after drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 48 h after drug administration ]
  5. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 48 h after drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: up to 48 h after drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 48 h after drug administration ]
  8. MRTpo (mean residence time of the analyte in the body after peroral administration) [ Time Frame: up to 48 h after drug administration ]
  9. CL/F (clearance of the analyte in plasma after peroral administration) [ Time Frame: up to 48 h after drug administration ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose) [ Time Frame: up to 48 h after drug administration ]
  11. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 48 h after drug administration ]
  12. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 48 h after drug administration ]
  13. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 48 h after drug administration ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

  2. Age ≥21 and ≤55 years
  3. BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
  2. Evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
  8. 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
  9. 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 enrolment in the study or during the study
  10. Participation in another trial with an investigational drug within 30 days prior to randomisation
  11. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  12. Inability to refrain from smoking on trial days as judged by the investigator
  13. Alcohol abuse (regularly more than 40 g alcohol per day)
  14. Drug abuse
  15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
  16. Excessive physical activities within 1 week prior to randomisation or during the trial
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. 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 anticholinergic drugs:

  19. History of hypersensitivity to tiotropium and/or related drugs of these classes
  20. History of narrow-angle glaucoma
  21. History of prostatic hyperplasia
  22. History of bladder-neck obstruction

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254135     History of Changes
Other Study ID Numbers: 1205.20
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014