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

A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Volunteers After Inhalative Administration of BIBN 4096 BS (Dosage: 5 - 80 mg)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIBN 4096 BS - in single rising doses

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIBN 4096 BS - in single rising doses	Drug: BIBN 4096 BS - in single rising doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): August 1, 2001

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1149.37