CompletedNCT02194777Updated Jul 23, 2014

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

A Phase 1 interventional study of BIBN 4096 BS - in single rising doses and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-23.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study 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 studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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
As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG) and a lung function test (Raw, SGaw). Moreover laboratory parameters (including drug screening, HBs-antigen (HBs-Ag), anti HBc-antibodies, anti HCV- antibodies and Human immunodeficiency virus (HIV) test as well as pregnancy test for female subjects are to be determined

Exclusion criteria

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Double
Enrollment: 48 participants (actual)

Study arms

Experimental
BIBN 4096 BS - in single rising doses
Drug: BIBN 4096 BS - in single rising doses
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugBIBN 4096 BS - in single rising doses
DrugPlacebo

What researchers measure

Primary outcomes

Number of patients with adverse events
Time frame: up to 24 days
Change in lung function measurement specific conductance (SGaw)
Time frame: up to 5 hours after drug administration
Assessment of tolerability on a 4-point scale
Time frame: 8 days after drug administration
Change in lung function measurement airway resistance (Raw)
Time frame: up to 5 hours after drug administration
Number of patients with clinically relevant changes in Blood Pressure
Time frame: up to 24 days
Number of patients with clinically relevant changes in Pulse Rate
Time frame: up to 24 days
Number of patients with clinically relevant changes in Electrocardiogram
Time frame: up to 24 days
Number of patients with clinically relevant changes in standard laboratory evaluation
Time frame: up to 24 days

Secondary outcomes

Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 48 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours after drug administration
λz (Terminal rate constant in plasma)
Time frame: up to 48 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 48 hours after drug administration
MRTtot (Total mean residence time of the analyte molecules in the body)
Time frame: up to 48 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 48 hours after drug administration
CLR (Renal clearance of the analyte in plasma)
Time frame: up to 48 hours after drug administration
Ae (Amount of parent drug excreted into urine)
Time frame: up to 24 hours after drug administration

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02194777
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Jul 18, 2014
Start date: Jun 2001
Primary completion: Aug 2001
Last update: Jul 23, 2014

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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