HealthyPhase 1NCT02229838
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
A Phase 1 study testing BIBB 1464 MS tablet, BIBB 1464 MS solution and Standard dinner in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level). Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. Read more about this study
- Who is it for?
- Ages 19 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBB 1464 MS tablet, BIBB 1464 MS solution and Standard dinner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Sep 1999
- 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 19 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age > 18 and < 55 years
- Broca > - 20% and < + 20%
Who cannot join
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease 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
- Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
- Inability to refrain from smoking during the period of the study
- Known alcohol (>60 g/day) or drug abuse
- Blood donation (<=1 month prior to administration)
- Excessive physical activities (<5 days prior to administration)
- Any laboratory value outside the normal range of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
About this study
Official title: Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).
Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)
Read more
Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
- Conditions
- Healthy
- Being tested
- BIBB 1464 MS tablet, BIBB 1464 MS solution, BIBB 1464 MS placebo, Standard dinner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBB 1464 MS tabletDrug
BIBB 1464 MS solutionDrug
BIBB 1464 MS placeboDrug
Standard dinnerOther
| Study group | Role | What they receive |
|---|---|---|
| BIBB 1464 MS single rising dose fed | Experimental | Not described Receives: Drug: BIBB 1464 MS tablet; Other: Standard dinner |
| BIBB 1464 MS tablet fasted | Experimental | Not described Receives: Drug: BIBB 1464 MS tablet |
| BIBB 1464 MS solution fasted | Active comparator | Not described Receives: Drug: BIBB 1464 MS solution |
| BIBB 1464 MS placebo | Placebo comparator | Not described Receives: Drug: BIBB 1464 MS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug plasma concentration (Cmax)
Measured: Up to 38 hours after drug administration
Time to reach the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 38 hours after drug administration
Total area under the plasma drug concentration-time curve (AUC)
Measured: Up to 38 hours after drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 38 hours after drug administration
Total plasma clearance divided by the systemic availability factor (CL/f)
Measured: Up to 38 hours after drug administration
Dose normalized AUC0-38h ( NAUC0-38h)
Measured: Up to 38 h after drug administration
Mean residence time, total (MRTtot)
Measured: Up to 38 hours after drug administration
Number of patients with adverse events
Measured: Up to 72 hours after last drug administration
Number of patients with clinical significant findings in vital signs
Measured: Up to 38 hours after drug administration
Number of patients with clinical significant findings in electrocardiogram (ECG)
Measured: Up to 38 hours after drug administration
Number of patients with clinical significant findings in physical examination
Measured: Up to 38 hours after drug administration
Investigator assessed tolerability on a 4 point scale
Measured: Up to 38 hours after drug administration
Monoepoxysqualene (MES) plasma concentration
Measured: Up to 38 hours after drug administration
Amount of drug excreted in urine
Measured: Up to 38 h 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 posted1 Sep 2014 (estimated)
- Study startJul 1999
- Primary completionSep 1999
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
- 73 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
- NCT02229838
- Sponsor's protocol ID
- 1178.1
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)
- ClinicalTrials.gov ID
- NCT02229838
- Acronym / sponsor ID
- 1178.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Primary completion
- Sep 1999 (actual)
- First posted
- 1 Sep 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.
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).
Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)
Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIBB 1464 MS single rising dose fed | Experimental | Drug: BIBB 1464 MS tablet, Other: Standard dinner |
| BIBB 1464 MS tablet fasted | Experimental | Drug: BIBB 1464 MS tablet |
| BIBB 1464 MS solution fasted | Active comparator | Drug: BIBB 1464 MS solution |
| BIBB 1464 MS placebo | Placebo comparator | Drug: BIBB 1464 MS placebo |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age > 18 and < 55 years
- Broca > - 20% and < + 20%
Key exclusion criteria (18 listed)
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease 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 |
|---|---|---|
| BIBB 1464 MS tablet | Drug | BIBB 1464 MS single rising dose fed, BIBB 1464 MS tablet fasted |
| BIBB 1464 MS solution | Drug | BIBB 1464 MS solution fasted |
| BIBB 1464 MS placebo | Drug | BIBB 1464 MS placebo |
| Standard dinner | Other | BIBB 1464 MS single rising dose fed |
Primary outcome
Maximum drug plasma concentration (Cmax)
Time frame: Up to 38 hours after drug administration
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 38 hours after drug administration
Total area under the plasma drug concentration-time curve (AUC)
Time frame: Up to 38 hours after drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 38 hours after drug administration
Total plasma clearance divided by the systemic availability factor (CL/f)
Time frame: Up to 38 hours after drug administration
Dose normalized AUC0-38h ( NAUC0-38h)
Time frame: Up to 38 h after drug administration
Mean residence time, total (MRTtot)
Time frame: Up to 38 hours after drug administration
Number of patients with adverse events
Time frame: Up to 72 hours after last drug administration
Number of patients with clinical significant findings in vital signs
Time frame: Up to 38 hours after drug administration
Number of patients with clinical significant findings in electrocardiogram (ECG)
Time frame: Up to 38 hours after drug administration
Number of patients with clinical significant findings in physical examination
Time frame: Up to 38 hours after drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 38 hours after drug administration
Monoepoxysqualene (MES) plasma concentration
Time frame: Up to 38 hours after drug administration
Amount of drug excreted in urine
Time frame: Up to 38 h 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 1 Sep 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 BIBB 1464 MS tablet, BIBB 1464 MS solution and Standard dinner 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 1 Sep 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?
Maximum drug plasma concentration (Cmax) (time frame: Up to 38 hours after drug administration). The study lists 14 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 1 Sep 2014.