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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743015
• Other study ID #: 1246.21
• Secondary ID: EudraCT 2008-001
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2008
• Last updated: October 31, 2013
• Start date: September 2008

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPGermany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• BI 44370 TA tablet

Locations

Country	Name	City	State
Belgium	1246.21.32001 Boehringer Ingelheim Investigational Site	Leuven
Germany	1246.21.49001 Boehringer Ingelheim Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum concentration of BI 44370 BS in plasma)		48 hours	No
Primary	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	No
Primary	AUC0-8 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)		48 hours	No
Primary	tmax (time from dosing to maximum measured concentration)		48 hours	No
Secondary	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	No
Secondary	%AUCtz-8 (the percentage of the AUC0-8 that is obtained by extrapolation)		48 hours	No
Secondary	AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)		48 hours	No
Secondary	?z (terminal rate constant in plasma)		48 hours	No
Secondary	t1/2 (terminal half-life of BI 44370 BS in plasma)		48 hours	No
Secondary	MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)		48 hours	No
Secondary	CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)		48 hours	No
Secondary	Vz/F (apparent volume of distribution during the terminal phase ?z following an extravascular dose)		48 hours	No
Secondary	Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)		48 hours	No
Secondary	fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)		48 hours	No
Secondary	CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)		48 hours	No
Secondary	Changes from baseline in Physical examination		48 hours	No
Secondary	Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)		48 hours	Yes
Secondary	Changes from baseline in 12-lead electrocardiogram (ECG)		48 hours	No
Secondary	Occurrence of Adverse events (AEs)		48 hours	No
Secondary	Assessment of tolerability by investigator		48 hours	No
Secondary	Number of participants with abnormalities in clinical laboratory parameters		48 hours	No