HealthyPhase 1NCT02256787
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food
A Phase 1 study testing BILB 1941 ZW - single rising dose part, BILB 1941 ZW - solution and BILB 1941 ZW - tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated 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?
- BILB 1941 ZW - single rising dose part, BILB 1941 ZW - solution and BILB 1941 ZW - tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Sep 2004
- 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 (BP, PR), 12-lead ECG, clinical laboratory tests:
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
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, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of 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) which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- 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 1 month prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation of more than 100 mL 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 and of clinical relevance
- History of any familial bleeding disorder
About this study
Official title: Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 120 mg, 200 mg, 300 mg, 600 mg, 1000 mg, 1500 mg, 2000 mg, 2400 mg, and 3000 mg BILB 1941 ZW (PEG 400/TRIS Solution) in Healthy Male Subjects, in a Randomised Double Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Three-Way Crossover Bioavailability Comparison of 600 mg BILB 1941 ZW in a PEG 400/TRIS Solution and 600 mg BILB 1941 ZW Tablet and 600 mg BILB 1941 ZW Tablet Administered With Food
The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated
- Conditions
- Healthy
- Being tested
- BILB 1941 ZW - single rising dose part, Placebo, BILB 1941 ZW - solution, BILB 1941 ZW - tablet, standardized breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILB 1941 ZW - single rising dose partDrug
PlaceboDrug
BILB 1941 ZW - solutionDrug
BILB 1941 ZW - tabletDrug
standardized breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| BILB 1941 ZW - single rising dose | Experimental | Single rising dose part Receives: Drug: BILB 1941 ZW - single rising dose part |
| Placebo | Placebo comparator | Single rising dose part Receives: Drug: Placebo |
| BILB 1941 ZW - tablet - fasted | Experimental | Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast Receives: Drug: BILB 1941 ZW - tablet |
| BILB 1941 ZW - solution | Experimental | Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast Receives: Drug: BILB 1941 ZW - solution |
| BILB 1941 ZW - tablet - fed | Experimental | Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast Receives: Drug: BILB 1941 ZW - tablet; Other: standardized breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal findings in physical examination
Measured: up to 48 hours following drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 48 hours following drug administration
Number of subjects with clinically significant changes in vital signs
Blood pressure, Pulse Rate
Measured: up to 48 hours following drug administration
Number of subjects with adverse events
Measured: up to 48 hours following drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Measured: up to 48 hours following drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: after 48 hours following drug administration
Secondary outcomes (8)
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 48 hours following drug administration
tmax (time from dosing to maximum concentration)
Measured: up to 48 hours following drug administration
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 48 hours following drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 48 hours following drug administration
λz (terminal rate constant in plasma)
Measured: up to 48 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 48 hours following drug administration
MRT (Mean time of residence of drug molecules in the body after intravascular administration)
Measured: up to 48 hours following drug administration
Vz/F (Apparent volume of distribution during the terminal phase after extravascular administration)
Measured: up to 48 hours following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startJan 2004
- Primary completionSep 2004
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 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
- NCT02256787
- Sponsor's protocol ID
- 1201.1
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 120 mg, 200 mg, 300 mg, 600 mg, 1000 mg, 1500 mg, 2000 mg, 2400 mg, and 3000 mg BILB 1941 ZW (PEG 400/TRIS Solution) in Healthy Male Subjects, in a Randomised Double Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Three-Way Crossover Bioavailability Comparison of 600 mg BILB 1941 ZW in a PEG 400/TRIS Solution and 600 mg BILB 1941 ZW Tablet and 600 mg BILB 1941 ZW Tablet Administered With Food
- ClinicalTrials.gov ID
- NCT02256787
- Acronym / sponsor ID
- 1201.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Sep 2004 (actual)
- First posted
- 6 Oct 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 objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BILB 1941 ZW - single rising dose | Experimental | Drug: BILB 1941 ZW - single rising dose partSingle rising dose part |
| Placebo | Placebo comparator | Drug: PlaceboSingle rising dose part |
| BILB 1941 ZW - tablet - fasted | Experimental | Drug: BILB 1941 ZW - tabletRelative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast |
| BILB 1941 ZW - solution | Experimental | Drug: BILB 1941 ZW - solutionRelative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast |
| BILB 1941 ZW - tablet - fed | Experimental | Drug: BILB 1941 ZW - tablet, Other: standardized breakfastRelative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Key exclusion criteria (16 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, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of 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 |
|---|---|---|
| BILB 1941 ZW - single rising dose part | Drug | BILB 1941 ZW - single rising dose |
| Placebo | Drug | Placebo |
| BILB 1941 ZW - solution | Drug | BILB 1941 ZW - solution |
| BILB 1941 ZW - tablet | Drug | BILB 1941 ZW - tablet - fasted, BILB 1941 ZW - tablet - fed |
| standardized breakfast | Other | BILB 1941 ZW - tablet - fed |
Primary outcome
Number of subjects with abnormal findings in physical examination
Time frame: up to 48 hours following drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 48 hours following drug administration
Number of subjects with clinically significant changes in vital signs
Time frame: up to 48 hours following drug administration
Blood pressure, Pulse Rate
Number of subjects with adverse events
Time frame: up to 48 hours following drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Time frame: up to 48 hours following drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: after 48 hours following drug administration
8 secondary outcomes
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 48 hours following drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 48 hours following drug administration
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 following drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours following drug administration
MRT (Mean time of residence of drug molecules in the body after intravascular administration)
Time frame: up to 48 hours following drug administration
Vz/F (Apparent volume of distribution during the terminal phase after extravascular administration)
Time frame: up to 48 hours following 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 6 Oct 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 BILB 1941 ZW - single rising dose part, BILB 1941 ZW - solution and BILB 1941 ZW - tablet 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 16 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 6 Oct 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?
Number of subjects with abnormal findings in physical examination (time frame: up to 48 hours following drug administration). The study lists 6 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 6 Oct 2014.