Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers

NCT02172105 | Completed Phase 1

• 1 other identifier: 1222.21
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of patients with abnormal findings in physical examination

  Baseline, up to 13 days after last drug administration

• Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)

  Baseline, up to 13 days after last drug administration

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

  Baseline, up to 13 days after last drug administration

• Number of patients with clinically significant changes in clinical laboratory tests

  Baseline, up to 13 days after last drug administration

• Change from baseline in potassium level

  Baseline and Day 14

• Number of patients with adverse events

  7 weeks

• Assessment of tolerability on a 4-point scale

  Day 28

Secondary Outcomes (17)

• Cmax (maximum measured concentration of the analyte in plasma at different time points)

  Up to day 18

• tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)

  Up to day 18

• AUC (area under the concentration-time curve of the analyte in plasma at different time points)

  Up to day 18

• %AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)

  Up to day 18

• λz (terminal rate constant in plasma at different time points)

  Up to day 18

Study Arms (2)

BI 1744 CL

EXPERIMENTAL

Drug: BI 1744 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1744 CL DRUG

BI 1744 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥20 and ≤35 years
• Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
• Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler

You may not qualify if:

• Any finding of the medical examination (including ,blood pressure and pulse rate and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 drug or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug before drug administration or during the trial
• Use of prescription or non-prescription drugs within 10 days before drug administration or during the trial. However, over-the-counter drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
• Participation in another trial with an investigational drug within four months before drug administration or during the trial
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
• Drug abuse

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: January 1, 2008
• Primary Completion: May 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06