Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS for HandiHaler® in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: High dose of BIBW 2948 BS for oral inhalation; Drug: Placebo; Drug: Low dose of BIBW 2948 BS for oral inhalation; Drug: Medium dose of BIBW 2948 BS for oral inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216461

1219.3

Details and patient eligibility

About

To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated dosing

Enrollment: 36 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males based on a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥21 and Age ≤ 50 years
• BMI (Body Mass Index) ≥18.5 and BMI ≤ 29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
• Subjects must be current smokers (<10 cigarettes or <3 cigars <3 pipes/day) with a smoking history >1 year

Exclusion criteria

• Any finding of the medical examination (including BP, PR 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
• 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)
• 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 prior to administration or during the trial
• Use of drugs which may have reasonably influenced the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to 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)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of study centre

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

Low dose of BIBW 2948 BS

Experimental group

Treatment:

Drug: Low dose of BIBW 2948 BS for oral inhalation

Medium dose of BIBW 2948 BS

Experimental group

Treatment:

Drug: Medium dose of BIBW 2948 BS for oral inhalation

High dose of BIBW 2948 BS

Experimental group

Treatment:

Drug: High dose of BIBW 2948 BS for oral inhalation

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo