Clinical trial NCT00743015: Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.)

Primary outcomes:
measure: Cmax (maximum concentration of BI 44370 BS in plasma)
timeFrame: 48 hours
measure: 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)
timeFrame: 48 hours
measure: AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: 48 hours
measure: tmax (time from dosing to maximum measured concentration)
timeFrame: 48 hours
Secondary outcomes:
measure: 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)
timeFrame: 48 hours
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
timeFrame: 48 hours
measure: AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)
timeFrame: 48 hours
measure: λz (terminal rate constant in plasma)
timeFrame: 48 hours
measure: t1/2 (terminal half-life of BI 44370 BS in plasma)
timeFrame: 48 hours
measure: MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)
timeFrame: 48 hours
measure: CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)
timeFrame: 48 hours
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: 48 hours
measure: Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
timeFrame: 48 hours
measure: fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
timeFrame: 48 hours
measure: CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)
timeFrame: 48 hours
measure: Changes from baseline in Physical examination
timeFrame: 48 hours
measure: Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)
timeFrame: 48 hours
measure: Changes from baseline in 12-lead electrocardiogram (ECG)
timeFrame: 48 hours
measure: Occurrence of Adverse events (AEs)
timeFrame: 48 hours
measure: Assessment of tolerability by investigator
timeFrame: 48 hours
measure: Number of participants with abnormalities in clinical laboratory parameters
timeFrame: 48 hours
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: 1246.21.32001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1246.21.49001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: