Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

NCT02183363 | Completed Phase 1

• 1 other identifier: 1218.25
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  predose, up to 24 hours

Secondary Outcomes (19)

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

  predose, up to 264 hours

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

  predose, up to 264 hours

• 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 264 hours

• AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

  predose, up to 264 hours

• C24 (plasma concentration of the analyte 24 hours after dosing)

  predose, up to 264 hours

Study Arms (3)

BI 1356 - Tablet TFII

EXPERIMENTAL

Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb

BI 1356 - Tablet iFF

EXPERIMENTAL

Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb

BI 1356 - Tablet TFIIb

ACTIVE COMPARATOR

Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb

Interventions

BI 1356 - Tablet TFII DRUG

BI 1356 - Tablet TFII; BI 1356 - Tablet TFIIb; BI 1356 - Tablet iFF

BI 1356 - Tablet iFF DRUG

BI 1356 - Tablet TFII; BI 1356 - Tablet TFIIb; BI 1356 - Tablet iFF

BI 1356 - Tablet TFIIb DRUG

BI 1356 - Tablet TFII; BI 1356 - Tablet TFIIb; BI 1356 - Tablet iFF

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, Blood Pressure (BP), Pulse Rate (PR), 12-lead Electrocardiogram (ECG), clinical laboratory tests
• No findings deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥21 and Age ≤55 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• 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:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: July 4, 2014
• First Posted: July 8, 2014
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Last Updated: July 8, 2014

Record last verified: 2014-07