Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBN 4096 BS- in single rising doses

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02198326

1149.3

Details and patient eligibility

About

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing doses in healthy male and female volunteers

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
Within +- 20% of their normal weight (Broca-Index)
All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral; sterilized) and must have a negative pregnancy test
In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
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) within 14 days before the first administration of the test substance
Haematopoietic, 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

Exclusion criteria

Volunteers will be excluded from the study if the results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
History of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections (especially common cold with rhinitis)
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of a drug with a long half-life (>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
Participation in another study with an investigational drug within the last two months preceding this study
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
Inability to refrain from smoking on study days
Alcohol abuse (> 40g/day)
Drug abuse
Blood donation ( >= 100 ml) within the last 4 weeks
Excessive physical activities (e.g. competitive sports) within the last week before the study
Pregnant and/or lactating volunteers