Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers

A Double-blind, Placebo-controlled Single Rising Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Intravenous Administration of BIBN 4096 BS (Dosage: 0.1 - 10 mg)

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intravenous 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): 55
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 volunteers are supposed to give their 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel 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 subjects with adverse events	up to 2 months
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate)	up to 8 days after last study day
Number of subjects with abnormal changes in laboratory parameters	up to 8 days after last study day
Number of subjects with clinically relevant changes in venous-occlusion plethysmography	up to 8 hours after drug administration
Number of subjects with clinically significant changes in ECG (Electrocardiogram)	up to 8 days after last study day

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 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)	up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)	up to 24 hours after drug administration
MRT (Mean residence time of the analyte in the body)	up to 24 hours after drug administration
CL (Total clearance of the analyte in plasma following extravascular administration)	up to 24 hours after drug administration
Vz (Apparent volume of distribution during the terminal elimination phase)	up to 24 hours after drug administration
Vss (Volume of distribution at steady state)	up to 24 hours after drug administration
Percentage of urinary excretion of BIBN 4096 BS	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, 1998
• Primary Completion (Actual): August 1, 1998

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1149.1