Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers

NCT02171806 | Completed Phase 1

• 1 other identifier: 1222.2
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Number of patients with clinically significant changes in physical examination

  Baseline, day 32 (end-of-study examination)

• Number of patients with clinically significant changes in vital signs

  Baseline, up to day 32

• Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram)

  Baseline, up to day 32

• Number of patients with abnormal changes in laboratory tests

  Baseline, up to day 32

• Changes in airway resistance (Raw) measured by body plethysmography

  Baseline, up to day 32

• Changes in tremormetry parameters

  Baseline, up to day 32

• Number of patients with adverse events

  Up to day 32

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

  Day 32 (end-of-study examination)

Secondary Outcomes (17)

• Cmax (maximum concentration of the analyte in plasma)

  Up to 408 hours after drug administration

• tmax (time from dosing to maximum concentration)

  Up to 408 hours after drug administration

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

  Up to 408 hours after drug administration

• Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2)

  Up to 384 hours after drug administration

• fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

  Up to 384 hours after drug administration

Study Arms (3)

BI 1744 CL multiple rising doses

EXPERIMENTAL

Drug: BI 1744 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BI 1744 CL medium dose, females

EXPERIMENTAL

Drug: BI 1744 CL

Interventions

BI 1744 CL DRUG

BI 1744 CL medium dose, females; BI 1744 CL multiple 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:

• Healthy male or female based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (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
• 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 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 60 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

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, 2006
• Primary Completion: September 1, 2006
• Last Updated: June 24, 2014

Record last verified: 2014-06