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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183363

1218.25

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of study centre

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

BI 1356 - Tablet TFII

Experimental group

Treatment:

Drug: BI 1356 - Tablet TFIIb

Drug: BI 1356 - Tablet iFF

Drug: BI 1356 - Tablet TFII

BI 1356 - Tablet iFF

Experimental group

Treatment:

Drug: BI 1356 - Tablet TFIIb

Drug: BI 1356 - Tablet iFF

Drug: BI 1356 - Tablet TFII

BI 1356 - Tablet TFIIb

Active Comparator group

Treatment:

Drug: BI 1356 - Tablet TFIIb

Drug: BI 1356 - Tablet iFF

Drug: BI 1356 - Tablet TFII