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Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02171793
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses 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 : 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 (15, 30, 40 μg Free Cation) BI 1744 CL in Healthy Male Volunteers
Study Start Date : June 2007
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 1744 CL Drug: BI 1744 CL
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline, day 17 ]
  2. Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature) [ Time Frame: Baseline, up to day 17 ]
  3. Number of patients with clinically relevant abnormal findings in 12-lead electrocardiogram (ECG) [ Time Frame: Baseline, up to day 17 ]
  4. Number of patients with clinically significant changes in clinical laboratory tests [ Time Frame: Baseline, up to day 17 ]
  5. Number of patients with Adverse events (AEs) [ Time Frame: 5 weeks ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 17 ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 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: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 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: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  8. MRTpo (mean residence time of the analyte in the body after peroral administration) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  9. CL/F (apparent clearance of the analyte in plasma after peroral administration, will not be calculated for metabolites) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose, will not be calculated for metabolites) [ Time Frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration ]
  11. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration ]
  12. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 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: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration ]


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Age ≥21 and ≤45 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 (GCP) 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 enrolment in the study or during the study
  • Participation in another trial with an investigational drug within 30 days 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 (regularly more than 40 g alcohol per 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 β2 mimetic drugs:

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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171793     History of Changes
Other Study ID Numbers: 1222.19
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