- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182193
Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers
July 17, 2014 updated by: Boehringer Ingelheim
Safety and Relative Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules Charge 1 Compared to BIBF 1120 Soft Gelatine Capsules Charge 2 Compared to BIBF 1120 Administered as Drinking Solution Following Oral Administration to Healthy Male Volunteers in an Open, Randomised, Intra-individual, Crossover Comparison Design
To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively.
To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with GCP and local legislation
- Age ≥21 and ≤55 years
- Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of relevant orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy or its excipients) which is deemed relevant to the trial as judged by the investigator
- History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (more than 150 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Female gender
- Male subjects refuse to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
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: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIBF 1120 capsules charge 1
|
|
Experimental: BIBF 1120 capsules charge 2
|
|
Active Comparator: BIBF 1120 drinking solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Individual maximum observed concentrations of the analyte in plasma (Cmax)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24)
Time Frame: 1 h pre dose and up to 24 h after drug administration
|
1 h pre dose and up to 24 h after drug administration
|
time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Terminal rate constant in plasma (λz)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time Frame: 1 h pre dose and up to 48 h after drug administration
|
1 h pre dose and up to 48 h after drug administration
|
Change in vital signs (blood pressure, pulse rate)
Time Frame: Baseline, up to 24 hours after drug administration
|
Baseline, up to 24 hours after drug administration
|
Change in routine laboratory values
Time Frame: pre-dose, up to 48 hours after drug administration
|
pre-dose, up to 48 hours after drug administration
|
Change in ECG
Time Frame: pre-dose, 4 hours after drug administration, day 32
|
pre-dose, 4 hours after drug administration, day 32
|
Occurrence of adverse events
Time Frame: up to 32 days after drug administration
|
up to 32 days after drug administration
|
Assessment of tolerability by investigator on a 4 point scale
Time Frame: 48 hours after drug administration
|
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
September 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1199.21
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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