- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183428
Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers
July 4, 2014 updated by: Boehringer Ingelheim
Relative Bioavailability of BI 1356 and Glyburide After Concomitant Administration of Multiple Oral Doses of BI 1356 5 mg Once Daily and a Single Oral Dose of Glyburide 1.75 mg Compared With the Bioavailability of BI 1356 and Glyburide After Each Treatment Given Alone in Healthy Male and Female Volunteers (an Open Label, Randomised, Two-way Crossover Study of Phase I)
The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of 1.75 mg glyburide.
In addition, the effect of glyburide as a single oral dose of 1.75 mg being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was investigated.
Pharmacokinetic profiles of glyburide were determined when given alone or in combination with BI 1356.
Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD 1750 were determined at steady state of BI 1356 when given alone or in combination with glyburide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy females and males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead (ECG) Electrocardiogram, clinical laboratory tests
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial, including herbal products
- Participation in another trial 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 trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- Galactose intolerance
- Lactase deficiency
- Glucose-galactose-malabsorption
For all female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- No adequate contraception e.g. , sterilisation, IUD (intrauterine device), have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- Not willing or unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
- Partner is unwilling to use condoms
- Lactation period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 1356
Treatment sequence AB_C or C_AB
|
|
Active Comparator: Glyburide
Treatment sequence AB_C or C_AB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-infinity (area under the concentration-time curve of glyburide in plasma) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Cmax (maximum measured concentration of glyburide in plasma) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356
Time Frame: up to 48 h after drug administration
|
up to 48 h after drug administration
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356
Time Frame: up to 48 h after drug administration
|
up to 48 h after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 11 weeks
|
up to 11 weeks
|
λz (terminal rate constant in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
tmax (time from dosing to the maximum concentration of the analyte in plasma) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after po administration) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) for several time points
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Day 1 of treatment B, day 3 of treatment B and C
|
Day 1 of treatment B, day 3 of treatment B and C
|
AUC (area under the concentration-time curve of the analyte in plasma) for several time points
Time Frame: up to 48 h after drug administration
|
up to 48 h after drug administration
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
Time Frame: up to 48 h after drug administration
|
up to 48 h after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1218.30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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