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

NCT02216461 | Completed Phase 1

• 1 other identifier: 1219.3
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with clinically significant findings in vital signs

  Up to day 20 after start of treatment

• Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)

  Up to day 20 after start of treatment

• Number of patients with clinically significant findings in clinical laboratory tests

  Up to day 20 after start of treatment

• Number of patients with adverse events

  Up to day 41

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

  Up to day 20 after start of treatment

Secondary Outcomes (19)

• Maximum concentration of the analyte BIBW in plasma at different time points (Cmax)

  Pre-dose, up to 336 hours after start of treatment

• Time from dosing to maximum measured concentration of the analyte in plasma at different time points (tmax)

  Pre-dose, up to 336 hours after start of treatment

• area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ (AUCτ,1)

  Pre-dose, up to 336 hours after start of treatment

• The percentage of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞) that is obtained by extrapolation (%AUCtz-∞)

  Pre-dose, up to 336 hours after start of treatment

• Terminal rate constant of the analyte in plasma at different time points (λz)

  Pre-dose, up to 336 hours after start of treatment

Study Arms (4)

Low dose of BIBW 2948 BS

EXPERIMENTAL

Drug: Low dose of BIBW 2948 BS for oral inhalation

Medium dose of BIBW 2948 BS

EXPERIMENTAL

Drug: Medium dose of BIBW 2948 BS for oral inhalation

High dose of BIBW 2948 BS

EXPERIMENTAL

Drug: High dose of BIBW 2948 BS for oral inhalation

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of BIBW 2948 BS for oral inhalation DRUG

Low dose of BIBW 2948 BS

Medium dose of BIBW 2948 BS for oral inhalation DRUG

Medium dose of BIBW 2948 BS

High dose of BIBW 2948 BS for oral inhalation DRUG

High dose of BIBW 2948 BS

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: August 12, 2014
• First Posted: August 15, 2014
• Study Start: January 1, 2006
• Primary Completion: April 1, 2006
• Last Updated: August 15, 2014

Record last verified: 2014-08