Back to resultsRelative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BI 44370 TA tablet
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
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.)
Sites / Locations
- 1246.21.32001 Boehringer Ingelheim Investigational Site
- 1246.21.49001 Boehringer Ingelheim Investigational Site
Outcomes
Primary Outcome Measures
Cmax (maximum concentration of BI 44370 BS in plasma)
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)
AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)
tmax (time from dosing to maximum measured concentration)
Secondary Outcome Measures
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)
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)
λz (terminal rate constant in plasma)
t1/2 (terminal half-life of BI 44370 BS in plasma)
MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)
CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)
Changes from baseline in Physical examination
Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)
Changes from baseline in 12-lead electrocardiogram (ECG)
Occurrence of Adverse events (AEs)
Assessment of tolerability by investigator
Number of participants with abnormalities in clinical laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00743015
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
BI 44370 TA tablet
Primary Outcome Measure Information:
Title
Cmax (maximum concentration of BI 44370 BS in plasma)
Time Frame
48 hours
Title
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)
Time Frame
48 hours
Title
AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)
Time Frame
48 hours
Title
tmax (time from dosing to maximum measured concentration)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
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)
Time Frame
48 hours
Title
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time Frame
48 hours
Title
AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)
Time Frame
48 hours
Title
λz (terminal rate constant in plasma)
Time Frame
48 hours
Title
t1/2 (terminal half-life of BI 44370 BS in plasma)
Time Frame
48 hours
Title
MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)
Time Frame
48 hours
Title
CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)
Time Frame
48 hours
Title
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame
48 hours
Title
Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
Time Frame
48 hours
Title
fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)
Time Frame
48 hours
Title
CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)
Time Frame
48 hours
Title
Changes from baseline in Physical examination
Time Frame
48 hours
Title
Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)
Time Frame
48 hours
Title
Changes from baseline in 12-lead electrocardiogram (ECG)
Time Frame
48 hours
Title
Occurrence of Adverse events (AEs)
Time Frame
48 hours
Title
Assessment of tolerability by investigator
Time Frame
48 hours
Title
Number of participants with abnormalities in clinical laboratory parameters
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1246.21.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1246.21.49001 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
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