Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers

July 22, 2014 updated by: Boehringer Ingelheim

A Double-blind (Within Dose Groups), Placebo-controlled Single Rising Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Intranasal Administration of BIBN 4096 BS (Dosage: 2.5 - 20 mg)

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing doses in healthy male and female volunteers

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 volunteer is supposed to give his 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 (especially common cold with rhinitis)
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in nasal mucosa assessed by rhinoscopy
Time Frame: up to 2 hours after treatment
up to 2 hours after treatment
Changes in nasal flow and resistance assessed by rhinomanometry
Time Frame: up to 2 hours after treatment
up to 2 hours after treatment
Number of patients with adverse events
Time Frame: up to 24 days
up to 24 days

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC (Area under the concentration-time curve of the analyte in plasma)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
MRT (Mean residence time of the analyte in the body)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
t½ (Terminal half-life of the analyte in plasma)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
CL (systemic clearance)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration
Vd (Volume of distribution)
Time Frame: up to 12 hours after intranasal administration
up to 12 hours after intranasal administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

August 1, 1999

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 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

  • 1149.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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