Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers

NCT02194335 | Completed Phase 1

• 1 other identifier: 1149.34
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers. With respect to pharmacokinetics, it was of particular importance to investigate whether therapeutic plasma levels (for treatment of migraine) could have been achieved by oral administration of a BIBN 4096 BS formulation.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of patients with adverse events

  up to 24 days

• Number of patients with abnormal changes in laboratory parameters

  up to 8 days after drug administration

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

  up to 8 days after drug administration

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

  up to 8 days after drug administration

Secondary Outcomes (9)

• 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

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 24 hours after drug administration

• CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

  up to 24 hours after drug administration

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

  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
• Broca Index: within +- 20% of their normal weight
• Subsequently 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). 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. The above mentioned examinations will be performed within 14 days before the first administration of the test substance. In accordance with Good Clinical Practice (GCP) and local legislation all volunteers will have given 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
• Use of any drugs which might influence the results of the trial (within one 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 (\> 60 g/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)
• Any laboratory value outside the reference range of clinical relevance

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 17, 2014
• First Posted: July 18, 2014
• Study Start: October 1, 2000
• Primary Completion: December 1, 2000
• Last Updated: July 23, 2014

Record last verified: 2014-07