HealthyPhase 1NCT02182076
Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers
A Phase 1 study testing BIBF 1120 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Nov 2005
- 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 (Good Clinical Practice) 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 orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) 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 10 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 within 1 month 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 clinically accepted reference range
- Female gender
- Male subjects must agree 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 Pharmacokinetics/Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules With and Without Food to Healthy Male Volunteers in an Open, Randomised, Intra-individual Crossover Comparison Design
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
- Conditions
- Healthy
- Being tested
- BIBF 1120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
150 mg of BIBF 1120 ES soft gelatine capsules
| Study group | Role | What they receive |
|---|---|---|
| fasted administration of BIBF 1120 | Active comparator | 150 mg of BIBF 1120 ES soft gelatine capsules in fasting state Receives: Drug: BIBF 1120 |
| fed administration of BIBF 1120 | Experimental | three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal Receives: Drug: BIBF 1120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Cmax (maximum observed concentration in plasma)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Secondary outcomes (10)
tmax (time from dosing to reach Cmax)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
t1/2 (terminal half-life in plasma)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
MRTpo (mean residence time in the body)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
CL/F (apparent clearance in plasma following extravascular administration)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)
Measured: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Incidence and intensity of adverse events
Measured: up to 14 days
Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate)
Measured: up to 14 days
Changes from baseline in laboratory tests
Measured: up to 14 days
Assessment of global tolerability on a 4-point scale
Measured: Day 3 of each treatment period
Changes from baseline in 12-lead electrocardiogram
Measured: up to 14 days
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 startOct 2005
- Primary completionNov 2005
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02182076
- Sponsor's protocol ID
- 1199.17
- 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 Pharmacokinetics/Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules With and Without Food to Healthy Male Volunteers in an Open, Randomised, Intra-individual Crossover Comparison Design
- ClinicalTrials.gov ID
- NCT02182076
- Acronym / sponsor ID
- 1199.17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2005 (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.
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fasted administration of BIBF 1120 | Active comparator | Drug: BIBF 1120150 mg of BIBF 1120 ES soft gelatine capsules in fasting state |
| fed administration of BIBF 1120 | Experimental | Drug: BIBF 1120three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal |
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 (Good Clinical Practice) 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 orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric 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 1120150 mg of BIBF 1120 ES soft gelatine capsules | Drug | fasted administration of BIBF 1120, fed administration of BIBF 1120 |
Primary outcome
AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Cmax (maximum observed concentration in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
10 secondary outcomes
tmax (time from dosing to reach Cmax)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
t1/2 (terminal half-life in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
MRTpo (mean residence time in the body)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
CL/F (apparent clearance in plasma following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Incidence and intensity of adverse events
Time frame: up to 14 days
Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate)
Time frame: up to 14 days
Changes from baseline in laboratory tests
Time frame: up to 14 days
Assessment of global tolerability on a 4-point scale
Time frame: Day 3 of each treatment period
Changes from baseline in 12-lead electrocardiogram
Time frame: up to 14 days
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.
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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 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?
AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity) (time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug). 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.