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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBW 2992 MA2 - single rising dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171767

1200.80

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

Male

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Blood donation (more than 100 mL within 4 weeks prior to administration of the trial drug or during the trial)
Excessive physical activities (within 1 week prior to administration of the trial drug or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsades de Points, e.g., heart failure, hypokalemia, family history of Long QT Syndrome

Exclusion criteria specific for this study:

History of clinically relevant skin diseases, psoriasis or moderate/severe acne
History or evidence of interstitial lung disease
Males who are unwilling to use a medically acceptable method of contraception during the first 3 months after administration of the trial drug. Acceptable methods of contraception for use by male volunteers include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, barrier contraception or another medically accepted contraceptive method