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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BI 1744 CL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171780

1222.1

Details and patient eligibility

About

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

Enrollment

122 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
The subject has performed excessive physical activities within one week prior to randomisation
The subject has a laboratory value outside the reference range that is of clinical relevance
The subject is not able to comply with dietary regimen of the study centre.

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

The subject has a diagnosis of asthma or history of pulmonary hyperreactivity
The subject has a diagnosis of hyperthyrosis
The subject has a diagnosis of allergic rhinitis in need of treatment
The subject has a diagnosis of clinically relevant cardiac arrhythmia
The subject has a diagnosis of paroxysmal tachycardia (>100 beats per minute).

For female subjects:

Pregnancy
Positive pregnancy test
No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study
Inability to maintain this adequate contraception during the whole study period
Lactation period