Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers

NCT02259959 | Completed Phase 1

• 1 other identifier: 1237.2
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Number of subjects with clinically relevant findings in physical examination

  Up to day 32

• Number of subjects with clinically relevant findings in vital signs

  blood pressure, pulse rate

  Up to day 32

• Number of subjects with clinically relevant findings in 12-lead ECG

  Up to day 32

• Number of subjects with clinically relevant findings in laboratory tests

  Up to day 32

• Number of subjects witch clinically relevant changes in additional safety laboratory test parameters

  Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium

  up to 318 hours after start of treatment

• Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography

  Pre-dose, up to 408 hours after start of treatment

• Number of subjects with adverse events

  Up to day 32

• Global assessment of tolerability by investigator on a 4-point scale

  Up to day 32

Secondary Outcomes (19)

• Maximum concentration in plasma (Cmax)

  up to 504 hours after start of treatment

• Time from dosing to maximum concentration in plasma (tmax)

  up to 504 hours after start of treatment

• Area under the concentration-time curve in plasma (AUC)

  up to 504 hours after start of treatment

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

  up to 504 hours after start of treatment

• Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)

  up to 504 hours after start of treatment

Study Arms (2)

BI 1744 CL in combination with Tiotropium

EXPERIMENTAL

Drug: Single rising doses of BI 1744 CL, solution for oral inhalation; Drug: Tiotropium, fixed dose, solution for oral inhalation

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Single rising doses of BI 1744 CL, solution for oral inhalation DRUG

BI 1744 CL in combination with Tiotropium

Tiotropium, fixed dose, solution for oral inhalation DRUG

BI 1744 CL in combination with Tiotropium

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male based upon a complete medical history, including 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 ≤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

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 randomization
• 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

MeSH Terms

Interventions

Solutions; Inhalation; Tiotropium Bromide

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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 7, 2014
• First Posted: October 9, 2014
• Study Start: April 1, 2007
• Primary Completion: September 1, 2007
• Last Updated: October 9, 2014

Record last verified: 2014-10