HealthyPhase 1NCT02182193
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
A Phase 1 study testing BIBF 1120 capsules charge 1, BIBF 1120 capsules charge 2 and BIBF 1120 drinking solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBF 1120 capsules charge 1, BIBF 1120 capsules charge 2 and BIBF 1120 drinking solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: 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)
- Conditions
- Healthy
- Being tested
- BIBF 1120 capsules charge 1, BIBF 1120 capsules charge 2, BIBF 1120 drinking solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 capsules charge 1Drug
BIBF 1120 capsules charge 2Drug
BIBF 1120 drinking solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 capsules charge 1 | Experimental | Not described Receives: Drug: BIBF 1120 capsules charge 1 |
| BIBF 1120 capsules charge 2 | Experimental | Not described Receives: Drug: BIBF 1120 capsules charge 2 |
| BIBF 1120 drinking solution | Active comparator | Not described Receives: Drug: BIBF 1120 drinking solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞)
Measured: 1 h pre dose and up to 48 h after drug administration
Individual maximum observed concentrations of the analyte in plasma (Cmax)
Measured: 1 h pre dose and up to 48 h after drug administration
Secondary outcomes (12)
Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24)
Measured: 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)
Measured: 1 h pre dose and up to 48 h after drug administration
Terminal rate constant in plasma (λz)
Measured: 1 h pre dose and up to 48 h after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 h pre dose and up to 48 h after drug administration
Change in vital signs (blood pressure, pulse rate)
Measured: Baseline, up to 24 hours after drug administration
Change in routine laboratory values
Measured: pre-dose, up to 48 hours after drug administration
Change in ECG
Measured: pre-dose, 4 hours after drug administration, day 32
Occurrence of adverse events
Measured: up to 32 days after drug administration
Assessment of tolerability by investigator on a 4 point scale
Measured: 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startSep 2006
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182193
- Sponsor's protocol ID
- 1199.21
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02182193
- Acronym / sponsor ID
- 1199.21
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2006 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 capsules charge 1 | Experimental | Drug: BIBF 1120 capsules charge 1 |
| BIBF 1120 capsules charge 2 | Experimental | Drug: BIBF 1120 capsules charge 2 |
| BIBF 1120 drinking solution | Active comparator | Drug: BIBF 1120 drinking solution |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF 1120 capsules charge 1 | Drug | BIBF 1120 capsules charge 1 |
| BIBF 1120 capsules charge 2 | Drug | BIBF 1120 capsules charge 2 |
| BIBF 1120 drinking solution | Drug | BIBF 1120 drinking solution |
Primary outcome
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
Individual maximum observed concentrations of the analyte in plasma (Cmax)
Time frame: 1 h pre dose and up to 48 h after drug administration
12 secondary outcomes
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
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
Terminal rate constant in plasma (λz)
Time frame: 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
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
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
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
Change in vital signs (blood pressure, pulse rate)
Time frame: Baseline, up to 24 hours after drug administration
Change in routine laboratory values
Time frame: pre-dose, up to 48 hours after drug administration
Change in ECG
Time frame: pre-dose, 4 hours after drug administration, day 32
Occurrence of adverse events
Time frame: up to 32 days after drug administration
Assessment of tolerability by investigator on a 4 point scale
Time frame: 48 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBF 1120 capsules charge 1, BIBF 1120 capsules charge 2 and BIBF 1120 drinking solution in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.