Safety, Tolerability and Pharmacokinetics of Inhalative Administration of BIBN 4096 BS in Healthy Male and Female Volunteers

NCT ID: NCT02194777

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIBN 4096 BS - in single rising doses

Group Type: EXPERIMENTAL

BIBN 4096 BS - in single rising doses

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIBN 4096 BS - in single rising doses

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants should be healthy males and females
• Age range from 21 to 50 years
• (Broca-Index): within +-20% of their normal weight
• In accordance with Good Clinical Practice (GCP) and local legislation all volunteers are supposed to give 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 a drug with a long half-life (> 24 hours) within at least 1 month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland/or ovaries)
• Use of any drugs which might influence the results of the trial within 1 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 (> 60g/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 device (IUD)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1149.37

Identifier Type: -

Identifier Source: org_study_id