Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers

NCT02171767 | Completed Phase 1

• 1 other identifier: 1200.80
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  predose, up to120 h after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  predose, up to 120 h after drug administration

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

  predose, up to 120 h after drug administration

Secondary Outcomes (14)

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

  predose, up to 120 h after drug administration

• AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 [predose] to 24 h)

  predose, up to 120 h after drug administration

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

  predose, up to 120 h after drug administration

• λz (terminal rate constant of the analyte in plasma)

  predose, up to 120 h after drug administration

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

  predose, up to 120 h days after drug administration

Study Arms (1)

BIBW 2992 MA2 - single rising dose

EXPERIMENTAL

Drug: BIBW 2992 MA2 - single rising dose

Interventions

BIBW 2992 MA2 - single rising dose DRUG

BIBW 2992 MA2 - single rising dose

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 (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), 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 (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including Blood Pressure (BP), Puse Rate (PR) and Electrocardiogram (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 1 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 administration of the trial drug or during the trial
• Participation in another trial with an investigational drug within 2 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 30 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

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

Record last verified: 2014-06