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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02171806
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1744 CL Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2.5 μg, 10 μg, and 30 μg) of BI 1744 CL for 14 Days in Healthy Male and Female Volunteers (Doubleblind, Randomised, Placebo Controlled [at Each Dose Level] Study)
Study Start Date : January 2006
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 1744 CL multiple rising doses Drug: BI 1744 CL
Placebo Comparator: Placebo Drug: Placebo
Experimental: BI 1744 CL medium dose, females Drug: BI 1744 CL



Primary Outcome Measures :
  1. Number of patients with clinically significant changes in physical examination [ Time Frame: Baseline, day 32 (end-of-study examination) ]
  2. Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, up to day 32 ]
  3. Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram) [ Time Frame: Baseline, up to day 32 ]
  4. Number of patients with abnormal changes in laboratory tests [ Time Frame: Baseline, up to day 32 ]
  5. Changes in airway resistance (Raw) measured by body plethysmography [ Time Frame: Baseline, up to day 32 ]
  6. Changes in tremormetry parameters [ Time Frame: Baseline, up to day 32 ]
  7. Number of patients with adverse events [ Time Frame: Up to day 32 ]
  8. Assessment of tolerability by the investigator on a 4-point scale [ Time Frame: Day 32 (end-of-study examination) ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: Up to 408 hours after drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: Up to 408 hours after drug administration ]
  3. AUC (area under the concentration-time curve of the analyte in plasma at different time points) [ Time Frame: Up to 408 hours after drug administration ]
  4. Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: Up to 384 hours after drug administration ]
  5. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: Up to 384 hours after drug administration ]
  6. %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) [ Time Frame: Up to 408 hours after drug administration ]
  7. λz (terminal rate constant of the analyte in plasma) [ Time Frame: Up to 408 hours after drug administration ]
  8. t½ (terminal half-life of the analyte in plasma) [ Time Frame: Up to 408 hours after drug administration ]
  9. MRTih (mean residence time of the analyte in the body after inhalation) [ Time Frame: Up to 408 hours after drug administration ]
  10. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: Up to 408 hours after drug administration ]
  11. Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose) [ Time Frame: Up to 408 hours after drug administration ]
  12. CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2) [ Time Frame: Up to 408 hours after drug administration ]
  13. RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) [ Time Frame: Up to 408 hours after drug administration ]
  14. RA,AUC,14 based on AUC0-τ [ Time Frame: Up to 408 hours after drug administration ]
  15. Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Up to 408 hours after drug administration ]
  16. Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) [ Time Frame: Up to 408 hours after drug administration ]
  17. Linearity Index (LI) [ Time Frame: Up to 408 hours after drug administration ]


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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (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
  • BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
  • 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 60 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).

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 2 months after release from the study.
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171806     History of Changes
Other Study ID Numbers: 1222.2
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents