HealthyPhase 1NCT02182258
Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects
A Phase 1 study testing BIBF 1120 soft gelatine capsule and BIBF 1120 intravenous solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBF 1120 soft gelatine capsule and BIBF 1120 intravenous solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Aug 2009
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 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, and clinical laboratory tests
- Age ≥18 years and ≤50 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Who cannot join
- Any finding from medical examination (including blood pressure, pulse rate, ECG) deviating from normal and of clinical relevance
- History of or current gastrointestinal, hepatic (including Gilbert's syndrome and history of bilirubin increases) renal, respiratory, cardiovascular, metabolic, immunological or 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 haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
- Intake of drugs with a long half-life (>24 h) within 1 month prior to administration or during the trial
- 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 the trial
- Smoker (>10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol abuse (>30 g/day)
- Drug abuse
- Blood donation (>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
- Male subjects refusing to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after completion of the study. Acceptable methods of contraception for male volunteers include vasectomy no less than 3 months prior to administration, barrier contraception, or a medically accepted contraceptive method. Acceptable methods of contraception for female partners of male volunteers include intra-uterine device, tubal ligation, hormonal contraceptive for at least 2 months and diaphragm with spermicide.
- Homozygous genotype status for UGT1A1*28, *60 (Gilbert polymorphisms)
About this study
Official title: Safety and Tolerability of Single Rising Doses of 1 mg, 3 mg, 10 mg and 20 mg of BIBF 1120 as Intravenous Infusion (Single-blind, Placebocontrolled at Each Dose Group) and Absolute Bioavailability of 100 mg BIBF 1120 as Soft Gelatine Capsule (Intra-individual Comparison)
The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single iv dosing, including dose proportionality.
- Conditions
- Healthy
- Being tested
- BIBF 1120 soft gelatine capsule, BIBF 1120 intravenous solution, Placebo ampoule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 soft gelatine capsuleDrug
BIBF 1120 intravenous solutionDrug
Placebo ampouleDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo ampoule |
| BIBF 1120 intravenous | Active comparator | Not described Receives: Drug: BIBF 1120 intravenous solution |
| BIBF 1120 capsule | Experimental | Not described Receives: Drug: BIBF 1120 soft gelatine capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 48 hours after drug administration
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 (AUC0-tz)
Measured: Up to 48 hours after drug administration
Secondary outcomes (21)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 48 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 48 hours after drug administration
%AUCtz-∞ (calculated from AUC0-∞ and AUC0-tz )
Measured: Up to 48 hours after drug administration
Terminal rate constant in plasma (λz)
Measured: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after iv administration (MRT)
Measured: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
Measured: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after intravenous administration (CL)
Measured: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravenous dose (Vz)
Measured: Up to 48 hours after drug administration
Apparent volume of distribution at steady-state following an intravenous dose (Vss)
Measured: Up to 48 hours after drug administration
Amount of analyte that is eliminated in urine within the time interval t1 to t2 (Aet1-t2)
Measured: Up to 48 hours after drug administration
Fraction of analyte excreted in urine within the time interval t1 to t2, in percentage of dose (fet1-t2)
Measured: Up to 48 hours after drug administration
Renal clearance of analyte within the time interval t1 to t2 (CLR,t1-t2)
Measured: Up to 48 hours after drug administration
Change from baseline in physical examination
Measured: Baseline, day 46
Change from baseline in vital signs (BP, PR)
Measured: Baseline, day 46
Change from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline, day 46
Change from baseline in clinical laboratory test (hematology, clinical chemistry and urinalysis)
Measured: Baseline, day 46
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to day 46
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Up to day Day 46
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 startJun 2009
- Primary completionAug 2009
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
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 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
- NCT02182258
- Sponsor's protocol ID
- 1199.75
- 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 Tolerability of Single Rising Doses of 1 mg, 3 mg, 10 mg and 20 mg of BIBF 1120 as Intravenous Infusion (Single-blind, Placebocontrolled at Each Dose Group) and Absolute Bioavailability of 100 mg BIBF 1120 as Soft Gelatine Capsule (Intra-individual Comparison)
- ClinicalTrials.gov ID
- NCT02182258
- Acronym / sponsor ID
- 1199.75
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (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.
The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single iv dosing, including dose proportionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo ampoule |
| BIBF 1120 intravenous | Active comparator | Drug: BIBF 1120 intravenous solution |
| BIBF 1120 capsule | Experimental | Drug: BIBF 1120 soft gelatine capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Age ≥18 years and ≤50 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Key exclusion criteria (18 listed)
- Any finding from medical examination (including blood pressure, pulse rate, ECG) deviating from normal and of clinical relevance
- History of or current gastrointestinal, hepatic (including Gilbert's syndrome and history of bilirubin increases) renal, respiratory, cardiovascular, metabolic, immunological or 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 soft gelatine capsule | Drug | BIBF 1120 capsule |
| BIBF 1120 intravenous solution | Drug | BIBF 1120 intravenous |
| Placebo ampoule | Drug | Placebo |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 48 hours after drug administration
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 (AUC0-tz)
Time frame: Up to 48 hours after drug administration
21 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 48 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 48 hours after drug administration
%AUCtz-∞ (calculated from AUC0-∞ and AUC0-tz )
Time frame: Up to 48 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after iv administration (MRT)
Time frame: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
Time frame: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after intravenous administration (CL)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravenous dose (Vz)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution at steady-state following an intravenous dose (Vss)
Time frame: Up to 48 hours after drug administration
Amount of analyte that is eliminated in urine within the time interval t1 to t2 (Aet1-t2)
Time frame: Up to 48 hours after drug administration
Fraction of analyte excreted in urine within the time interval t1 to t2, in percentage of dose (fet1-t2)
Time frame: Up to 48 hours after drug administration
Renal clearance of analyte within the time interval t1 to t2 (CLR,t1-t2)
Time frame: Up to 48 hours after drug administration
Change from baseline in physical examination
Time frame: Baseline, day 46
Change from baseline in vital signs (BP, PR)
Time frame: Baseline, day 46
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline, day 46
Change from baseline in clinical laboratory test (hematology, clinical chemistry and urinalysis)
Time frame: Baseline, day 46
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 46
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Up to day Day 46
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 soft gelatine capsule and BIBF 1120 intravenous 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 5 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. Some participants in this study may receive a placebo. 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 concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 48 hours 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.