Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks

Relative Bioavailability Following Single Oral Administration of 200 mg of BI 44370 During and Between Migraine Attacks in Male and Female Migraine Patients. An Open-label, Fixed-sequence, Two-period Study With Intraindividual Comparison

The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: BI 44370 TA tablet

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • 1246.21.32001 Boehringer Ingelheim Investigational Site
• Germany
  • Berlin, Germany
    • 1246.21.49001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult male and female migraine patients (age 18 to 65 years) with or without aura, diagnosed according to IHS criteria.
• Established migraine diagnosis for >= 1 year.
• Age at migraine onset <= 50 years.
• Well documented (for >= 3 months) retrospective history of migraine with headache of moderate to severe intensity and with an attack duration of at least 6 hours and migraine frequency of 2-8 times / month
• Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache.
• Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
• Patient is in general good health based om screening assessment

Exclusion Criteria:

• Women of child-bearing potential without an adequate method of contraception
• Any woman of child-bearing potential not having a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
• Breastfeeding women
• Males not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilization, IUD [intrauterine device]) during the whole study period from the time of the first intake of study drug until three months after the last intake.
• History of hemiplegic, ophthalmoplegic, or basilar migraine or cluster headache.
• History of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compounds.
• History of , clinical evidence for, or screening/baseline findings suggestive of significant medical disorders (e.g. cardiovascular, peripheral vascular, hepatic, respiratory, haematological, renal, gastrointestinal, immunological, metabolic, hormonal, neurological or psychiatric disorders)
• Smokers ... (cont.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Crossover Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum concentration of BI 44370 BS in plasma)	48 hours
AUC0-2 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to 2 h after drug administration)	48 hours
AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)	48 hours
tmax (time from dosing to maximum measured concentration)	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC0-tz (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to the time of the last quantifiable data point)	48 hours
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)	48 hours
AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)	48 hours
λz (terminal rate constant in plasma)	48 hours
t1/2 (terminal half-life of BI 44370 BS in plasma)	48 hours
MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)	48 hours
CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)	48 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	48 hours
Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)	48 hours
fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)	48 hours
CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)	48 hours
Changes from baseline in Physical examination	48 hours
Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)	48 hours
Changes from baseline in 12-lead electrocardiogram (ECG)	48 hours
Occurrence of Adverse events (AEs)	48 hours
Assessment of tolerability by investigator	48 hours
Number of participants with abnormalities in clinical laboratory parameters	48 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 1246.21; EudraCT 2008-001356-42