- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214953
Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers
August 12, 2014 updated by: Boehringer Ingelheim
An Open, Randomised, Single-dose, Four-way Cross-over Formulation Finding Study of the Oral Bioavailability of Four Prototype Extended Release Formulations With 25 mg BI 11634, and Intra-individual Comparison to Immediate-release Tablets (25 mg) in Healthy Male Volunteers
To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
17
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
21 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy Caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥21 and ≤45 years
- Haemoglobin within the normal ranges.
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
Exclusion Criteria:
- Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
- History of gastric ulcera and cholecystectomy
- Occult blood in faeces
- Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Relevant chronic or acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Alcohol abuse (more than 40 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 understand and comply with protocol requirements, instructions and protocol stated restrictions, the nature, scope and possible consequences of the study
- Subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
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 11634 ER formulation A
|
|
Experimental: BI 11634 ER formulation B
|
|
Experimental: BI 11634 ER formulation M
|
|
Experimental: BI 11634 ER formulation C
|
|
Active Comparator: BI 11634 IR tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 48 hours after drug administraton
|
up to 48 hours after drug administraton
|
Cmax (maximum measured concentration of analyte in plasma)
Time Frame: up to 48 hours after drug administraton
|
up to 48 hours after drug administraton
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
|
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
|
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
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)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
|
Number of subjects with clinically significant findings in ECG
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
MRTpo (mean residence time of the analyte in the body after oral administration)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
|
Fluctuation parameter Cmax/C24 ratio
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
|
Maximum prolongation of blood coagulation time
Time Frame: up to 48 hours after drug administration
|
by HepTest® (Haemachem Inc.)
|
up to 48 hours after drug administration
|
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
% Inhibition of Factor Xa
Time Frame: up to 48 hours after drug administration
|
by Russel's Viper Venom test (RVV)
|
up to 48 hours 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
October 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
August 12, 2014
First Submitted That Met QC Criteria
August 12, 2014
First Posted (Estimate)
August 13, 2014
Study Record Updates
Last Update Posted (Estimate)
August 13, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1234.7
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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