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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBW 2948 BS for oral inhalation; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02214901

1219.1

Details and patient eligibility

About

Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS

Enrollment: 91 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males based on a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:

  • No finding deviating from normal and of clinical relevance
  • No evidence of a clinically relevant concomitant disease

• Aged between ≥21 and ≤50 years

• BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2

• Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion criteria

• Any finding during 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 might reasonably influence 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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91 participants in 2 patient groups, including a placebo group

BIBW 2948 BS in single rising doses

Experimental group

Treatment:

Drug: BIBW 2948 BS for oral inhalation

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo