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

NCT02273401 | Completed Phase 1

• 1 other identifier: 1250.1
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, tolerability, and pharmacokinetics of BI 11054

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Number of subjects with clinically significant findings in physical examination

  up to 18 days after drug administration

• Number of subjects with clinically significant findings in vital signs

  blood pressure (BP), pulse rate (PR), respiratory rate (RR)

  up to 18 days after drug administration

• Number of subjects with clinically significant findings in orthostasis tests

  up to 24 hours after drug administration

• Number of subjects with clinically significant findings in laboratory tests

  up to 18 days after drug administration

• Number of subjects with clinically significant findings in additional safety laboratory tests

  cyclic adenosine monophosphate (cAMP) and potassium

  up to 24 hours after drug administration

• Number of subjects with clinically significant changes in body temperature

  up to 24 hours after drug administration

• Number of subjects with clinically significant findings in electrocardiogram (ECG)

  up to 18 days after drug administration

• Number of subjects with adverse events

  up to 18 days after drug administration

• Number of subjects with findings of oropharyngeal inspection

  up to 24 hours after drug administration

• Number of subjects with findings of pulmonary auscultation

  up to 24 hours after drug administration

• Airway resistance (Raw)

  measured by body plethysmography

  up to 24 hours after drug administration

• Global tolerability assessed by investigator on a 4-point scale

  up to 18 days after drug administration

Secondary Outcomes (14)

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 96 hours

• tmax (time from dosing to maximum measured concentration)

  up to 96 hours

• 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)

  up to 96 hours

• AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2)

  up to 96 hours

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 96 hours

Study Arms (2)

BI 11054 CL

EXPERIMENTAL

Drug: BI 11054 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 11054 CL DRUG

BI 11054 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: October 24, 2014

Record last verified: 2014-10