HealthyPhase 1NCT02223013
Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects
A Phase 1 study testing BIBV 308 SE solution, BIBV 308 SE capsule L and BIBV 308 SE capsule S in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBV 308 SE solution, BIBV 308 SE capsule L and BIBV 308 SE capsule S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to May 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
- 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
- Poor individual absorption kinetics of BIBV 308 SE in previous studies
- Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or acute relevant infections
Show all 20Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Hypersensitivity to BIBV 308 SE and any of the excipients
- 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 results of the trial <= 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug <= 2 months days 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 haemorrhagic diathesis
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
About this study
Official title: Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of 50 mg BIBV 308 SE Each, Versus a Solution of 50 mg BIBV 308 SE Administered Orally Twice a Day for 3.5 Days to Healthy Subjects (Cross-over, Open, Randomized)
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
- Conditions
- Healthy
- Being tested
- BIBV 308 SE solution, BIBV 308 SE capsule L, BIBV 308 SE capsule S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBV 308 SE solutionDrug
BIBV 308 SE capsule LDrug
BIBV 308 SE capsule SDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBV 308 SE solution | Active comparator | Not described Receives: Drug: BIBV 308 SE solution |
| BIBV 308 SE capsule L | Experimental | Not described Receives: Drug: BIBV 308 SE capsule L |
| BIBV 308 SE capsule S | Experimental | Not described Receives: Drug: BIBV 308 SE capsule S |
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 at steady state (AUCss)
Measured: up to 84 hours
Maximum plasma concentration at steady state (Cmax,ss)
Measured: up to 84 hours
Minimum plasma concentration at steady state (Cmin,ss)
Measured: up to 84 hours
Secondary outcomes (9)
Percent peak-to-trough fluctuation (%PTF)
Measured: up to 84 hours
Time to maximum plasma concentration in steady state (tmax,ss)
Measured: up to 84 hours
Mean residence time in steady state (MRT,ss)
Measured: up to 84 hours
Total plasma clearance (CL/f)
Measured: up to 84 hours
Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)
Measured: up to 84 hours
Number of patients with adverse events
Measured: up to 5 days after last drug administration
Number of patients with clinically significant findings in vital signs
pulse rate, blood pressure
Measured: up to 5 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
Measured: up to 5 days after last drug administration
Trough concentration of BIBV 308 SE before doses
Measured: up to 84 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startApr 1999
- Primary completionMay 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT02223013
- Sponsor's protocol ID
- 528.204
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of 50 mg BIBV 308 SE Each, Versus a Solution of 50 mg BIBV 308 SE Administered Orally Twice a Day for 3.5 Days to Healthy Subjects (Cross-over, Open, Randomized)
- ClinicalTrials.gov ID
- NCT02223013
- Acronym / sponsor ID
- 528.204
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- May 1999 (actual)
- First posted
- 22 Aug 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.
Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBV 308 SE solution | Active comparator | Drug: BIBV 308 SE solution |
| BIBV 308 SE capsule L | Experimental | Drug: BIBV 308 SE capsule L |
| BIBV 308 SE capsule S | Experimental | Drug: BIBV 308 SE capsule S |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
- 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 (20 listed)
- Poor individual absorption kinetics of BIBV 308 SE in previous studies
- Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
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 |
|---|---|---|
| BIBV 308 SE solution | Drug | BIBV 308 SE solution |
| BIBV 308 SE capsule L | Drug | BIBV 308 SE capsule L |
| BIBV 308 SE capsule S | Drug | BIBV 308 SE capsule S |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)
Time frame: up to 84 hours
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 84 hours
Minimum plasma concentration at steady state (Cmin,ss)
Time frame: up to 84 hours
9 secondary outcomes
Percent peak-to-trough fluctuation (%PTF)
Time frame: up to 84 hours
Time to maximum plasma concentration in steady state (tmax,ss)
Time frame: up to 84 hours
Mean residence time in steady state (MRT,ss)
Time frame: up to 84 hours
Total plasma clearance (CL/f)
Time frame: up to 84 hours
Quotient of Cmax,ss and AUCss (Cmax,ss/AUCss)
Time frame: up to 84 hours
Number of patients with adverse events
Time frame: up to 5 days after last drug administration
Number of patients with clinically significant findings in vital signs
Time frame: up to 5 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 5 days after last drug administration
Trough concentration of BIBV 308 SE before doses
Time frame: up to 84 hours
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 22 Aug 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 BIBV 308 SE solution, BIBV 308 SE capsule L and BIBV 308 SE capsule S 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 20 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 22 Aug 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 concentration-time curve of the analyte in plasma at steady state (AUCss) (time frame: up to 84 hours). The study lists 3 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 22 Aug 2014.