Study to Determine Tolerability of Single Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers

A Double-blind (Within Dose Groups), Randomized, Placebo-controlled Single Increasing Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Subcutaneous Administration of BIBN 4096 (Dosage: 2.5 - 30 mg)

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after single subcutaneous 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): 12
• 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
• All female volunteers must use a safe contraception (i.e. oral contraception, spiral, sterilized)
• All female volunteers must have a negative pregnancy test
• Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice (GCP) and local legislation) in writing 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 ECG within 14 days before the administration of the test substance. Hematopoietic, 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:

• 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 ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial within two weeks 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 (> 40g/day)
• Drug abuse
• Blood donation (>= 100 ml) within four weeks prior to administration or during the trial
• Excessive physical activities within five days prior to administration or during the trial
• 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 pessary (IUP)
• 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: PARALLEL
• 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
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)	up to 8 days after treatment day
Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)	up to 8 days after treatment day
Number of patients with abnormal changes in laboratory parameters	up to 8 days after treatment 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 48 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)	up to 48 hours after drug administration
Ae (Amount of drug excreted into urine)	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
MRT (Mean time of residence of drug molecules in the body)	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
CL(R) (Renal clearance of the analyte in plasma)	up to 48 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: February 1, 2000
• Primary Completion (ACTUAL): March 1, 2000

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: 1149.31