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

NCT02214901 | Completed Phase 1

• 1 other identifier: 1219.1
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature)

  Up to 8 days after start of treatment

• Changes from baseline in clinical laboratory tests

  Up to 8 days after start of treatment

• Changes from baseline in 12-lead electrocardiogram (ECG)

  Up to 8 days after start of treatment

• Number of patients with adverse events

  Up to day 29

• Changes from baseline in airway resistance (Raw)

  measured via plethysmography

  Pre-dose, up to 24 hours after start of treatment

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

  Up to 8 days after start of treatment

Secondary Outcomes (12)

• Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2)

  Pre-dose, up to 48 hours after start of treatment

• Maximum concentration of BIBW 3056 ZW in plasma (Cmax)

  Pre-dose, up to 48 hours after start of treatment

• Time from dosing to maximum concentration of the analytes in plasma (tmax)

  Pre-dose, up to 48 hours after start of treatment

• Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2)

  Pre-dose, up to 48 hours after start of treatment

• Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2)

  Pre-dose, up to 48 hours after start of treatment

Study Arms (2)

BIBW 2948 BS in single rising doses

EXPERIMENTAL

Drug: BIBW 2948 BS for oral inhalation

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBW 2948 BS for oral inhalation DRUG

BIBW 2948 BS in single rising doses

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 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

You may not qualify if:

• 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)

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 13, 2014
• Study Start: March 1, 2005
• Primary Completion: July 1, 2005
• Last Updated: August 13, 2014

Record last verified: 2014-08