BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) in Healthy Male Volunteers

NCT02171715 | Completed Phase 1

• 1 other identifier: 1200.35
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 96 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 96 hours after drug administration

Secondary Outcomes (10)

• AUC (area under the concentration-time curve of the analyte in plasma) for several time points

  up to 96 hours after drug administration

• %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation from the last quantifiable data point to infinity)

  up to 96 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 96 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 96 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 96 hours after drug administration

Study Arms (3)

BIBW 2992 MA2, final formulation

EXPERIMENTAL

Drug: BIBW 2992 MA2

BIBW 2992 MA2, trial formulation II

EXPERIMENTAL

Drug: BIBW 2992 MA2

BIBW 2992 MA 2 drinking solution

ACTIVE COMPARATOR

Drug: BIBW 2992 MA2

Interventions

BIBW 2992 MA2 DRUG

film-coated immediate release tablet - final formulation

BIBW 2992 MA2, final formulation

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to a complete medical history, including a physical examination, vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram), and clinical laboratory tests
• Age 21 to 55 years, inclusive
• Body mass index 18.5 to 29.9 kg/m2, inclusive
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

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
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 drug allergy or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within one month prior to administration of the trial drug or during the trial
• Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 10 days prior to first administration of the trial drug 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 within the in-house periods from 12 hours before until 25 hours after each administration of the trial drug
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06