Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BIBN 4096 BS - in single rising doses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194335

1149.34

Details and patient eligibility

About

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers. With respect to pharmacokinetics, it was of particular importance to investigate whether therapeutic plasma levels (for treatment of migraine) could have been achieved by oral administration of a BIBN 4096 BS formulation.

Enrollment: 32 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants should be healthy males and females
• Age range from 21 to 50 years
• Broca Index: within +- 20% of their normal weight
• Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG). Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance. In accordance with Good Clinical Practice (GCP) and local legislation all volunteers will have given their written informed consent prior to admission to the study

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
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological 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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
• Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial)
• Participation in another study 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 study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation (>= 100 ml) within four weeks prior to administration or during the trial
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance

For female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. oral contraceptives, sterilization, intrauterine pessary (IUP)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

BIBN 4096 BS - in single rising doses

Experimental group

Treatment:

Drug: BIBN 4096 BS - in single rising doses

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo