Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Standard breakfast (40 g fat)

Drug: BIBB 515 BS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02266498

525.4

Details and patient eligibility

About

To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules

Enrollment

8 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male caucasian subjects as determined by results of screening
Written informed consent in accordance with good clinical practice (GCP) and local legislation
Age ≥ 18 and ≤ 50 years
Broca ≥ - 20 % and ≤ + 20 %

Exclusion criteria

Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
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 neurologic disorders
History of 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) (≤ 1 month prior to administration or during the trial)
Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on study days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
Excessive physical activities (≤ 10 days prior to administration or during the trial)
Any laboratory value outside the reference range of clinical relevance