Safety, Tolerability and Pharmacokinetics After Administration of Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers

NCT02194322 | Completed Phase 1

• 1 other identifier: 1149.35
• Study Type: interventional
• Target: 38
• 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 intranasal administration of increasing doses in healthy male and female volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of patients with adverse events

  up to 24 days

• Number of patients with abnormal changes in laboratory parameters

  up to 24 days

• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)

  up to 24 days

• Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)

  up to 24 days

• Assessment of tolerability on a 4-point scale

  8 days after drug administration

• Macroscopic changes in nasal mucosa assessed by rhinoscopy

  up to 3 hours after drug administration

• Changes in nasal flow assessed by rhinomanometry

  up to 3 hours after drug administration

Secondary Outcomes (11)

• 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

• 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

• 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

• t½ (Terminal half-life of the analyte in plasma)

  up to 48 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
• Body Mass Index (BMI) is to be within 18.5 to 29.9 kg/m² (BMI calculation: weight in kilograms divided by the square of height in meters)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: November 1, 2001
• Primary Completion: January 1, 2002
• Last Updated: July 23, 2014

Record last verified: 2014-07