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Safety, Tolerability and Pharmacokinetics Study of BI 1744 CL in Healthy Male Subjects

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: BI 1744 CL
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL

Enrollment

64 patients

Sex

Male

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male 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 ≤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 and the local legislation

Exclusion criteria

  • 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 medication
  • 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 medication
  • Participation in another trial with an investigational drug within 2 months prior to medication
  • 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 medication or during the trial)
  • Excessive physical activities within 1 week prior to randomisation or during the trial
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of the study centre.

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

  • Asthma or history of pulmonary hyperreactivity
  • Hyperthyrosis
  • Allergic rhinitis in need of treatment
  • Clinically relevant cardiac arrhythmia
  • Paroxysmal tachycardia (>100 beats per minute)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups, including a placebo group

BI 1744 CL
Experimental group
Description:
Single rising dose of BI 1744 CL as intravenous (i.v.) infusion
Treatment:
Drug: BI 1744 CL
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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