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

NCT02198352 | Completed Phase 1

• 1 other identifier: 1149.1
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• 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

Study Arms (2)

BIBN 4096 BS - in single rising doses

EXPERIMENTAL

Drug: BIBN 4096 BS - in single rising doses

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBN 4096 BS - in single rising doses DRUG

BIBN 4096 BS - in single rising doses

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 23, 2014
• Study Start: June 1, 1998
• Primary Completion: August 1, 1998
• Last Updated: July 29, 2014

Record last verified: 2014-07