Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Pharmacokinetics of BEA 2180 BR 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: NCT02254720
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation

Condition or disease Intervention/treatment Phase
Healthy Drug: BEA 2180 BR solution for infusion Drug: Placebo Drug: BEA 2180 BR solution for inhalation Device: Respimat® Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 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 Intravenous Doses (2.5 μg, 7.5 μg, 25 μg, 50 μg, 100 μg, 200 μg, 350 μg, 500 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers With an Additional Arm by Inhalation in One Dose Group (1600 μg)
Study Start Date : September 2006
Actual Primary Completion Date : December 2006

Arm Intervention/treatment
Experimental: BEA 2180 BR IV
Rising doses
Drug: BEA 2180 BR solution for infusion
Placebo Comparator: Placebo Drug: Placebo
Intravenous infusion

Experimental: BEA 2180 BR inhalation Drug: BEA 2180 BR solution for inhalation
Device: Respimat®



Primary Outcome Measures :
  1. Number of participants with abnormal findings in physical examination [ Time Frame: Up to day 12 after drug administration ]
  2. Number of participants with clinically significant changes in vital signs [ Time Frame: Up to day 12 after drug administration ]
  3. Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram) [ Time Frame: Up to day 12 after drug administration ]
  4. Number of participants with abnormal changes in clinical laboratory parameters [ Time Frame: Up to day 12 after drug administration ]
  5. Number of participants with adverse events [ Time Frame: Up to day 12 after drug administration ]
  6. Investigator assessed tolerability on a 4-point scale [ Time Frame: Up to day 12 after drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 72 hours 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 72 hours after drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: Up to 72 hours 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 72 hours after drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  8. MRT(mean residence time of the analyte in the body) [ Time Frame: Up to 72 hours after drug administration ]
  9. CL (total clearance of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  10. Vz (apparent volume of distribution during the terminal phase λz) [ Time Frame: Up to 72 hours after drug administration ]
  11. Vss (apparent volume of distribution at steady state following intravascular administration) [ Time Frame: Up to 72 hours after drug administration ]
  12. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: Up to 72 hours after drug administration ]
  13. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: Up to 72 hours after drug administration ]
  14. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: Up to 72 hours after drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Age ≥21 and ≤50 years
  3. BMI ≥18.5 and <29.9 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 blood pressure (BP), pulse rate (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 2 months 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 for men)
  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. 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:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254720     History of Changes
Other Study ID Numbers: 1205.5
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions