A Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 1744 CL in Healthy Male and Female Volunteers

NCT02171780 | Completed Phase 1

• 1 other identifier: 1222.1
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Number of patients with abnormal findings in physical examination

  12 days after drug administration

• Number of patients with clinically significant changes in vital signs

  Baseline, up to 12 days after drug administration

• Change in orthostasis test parameters

  Baseline, up to 24 hours after drug administration

• Number of patients with abnormal changes in laboratory parameters

  Baseline, up to 12 days after drug administration

• Change in oral body temperature

  Baseline, up to 24 hours after drug administration

• Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters

  Baseline, up to 12 days after drug administration

• Number of patients with adverse events

  Up to 12 days

• Change in tremormetry parameters

  Baseline, up to 24 hours after drug administration

• Number of patients with abnormal findings of oropharyngeal inspection

  Baseline, up to 24 hours after drug administration

• Number of patients with abnormal findings of pulmonary auscultation

  Baseline, up to 24 hours after drug administration

• Change in airway resistance (Raw), as measured by body plethysmography

  Baseline, up to 24 hours after drug administration

• Assessment of tolerability by investigator on a 4-point scale

  12 days after drug administration

Secondary Outcomes (14)

• Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

  Up to 96 hours after drug administration

• Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to 24 hours (AUC0-24)

  Up to 96 hours after drug administration

• Maximum concentration of BI 1744 CL in plasma (Cmax)

  Up to 96 hours after drug administration

• Time from dosing to maximum concentration (tmax)

  Up to 96 hours after drug administration

• Amount of BI 1744 CLeliminated in urine from the time point t1 to time point t2 (Aet1-t2)

  Up to 96 hours after drug administration

Study Arms (2)

BI 1744 CL single rising doses

EXPERIMENTAL

Drug: BI 1744 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1744 CL DRUG

BI 1744 CL single rising doses

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• The subject is healthy 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
• The subject is at least 21 years old and not older than 50 years
• The subject's body mass index (BMI) is at least 18.5 kg/m2 and less than 30 kg/m2
• The subject has signed and dated a written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• The subject has any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
• The subject had a surgery of gastrointestinal tract (except appendectomy)
• The subject has a diagnosis of gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• The subject has a diagnosis of diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• The subject has a history of relevant orthostatic hypotension, fainting spells or blackouts
• The subject has a diagnosis of chronic or relevant acute infections
• The subject has a history of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
• The subject has taken drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to randomisation
• The subject has used 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
• The subject has participated in another trial with an investigational drug within two months prior to randomisation
• The subject is a heavily smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• The subject is not able to refrain from smoking on trial days as judged by the investigator
• The subject uses more than 60 g alcohol a day)
• The subject uses drugs
• The subject has donated more than 100 mL blood within four weeks prior to randomisation

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

olodaterol

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: February 1, 2005
• Primary Completion: July 1, 2005
• Last Updated: June 24, 2014

Record last verified: 2014-06