HealthyPhase 1NCT02209831
Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers
A Phase 1 study testing BIBR 796 BS and Pantoprazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed. 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?
- BIBR 796 BS and Pantoprazole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Jan 2002
- 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
- Healthy male 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
- Laboratory examinations within a clinically defined reference range
- Helicobacter pylori negative
- Able to tolerate pH probe application
- Body mass index (BMI) >=18.5 and <=29.9 kg/m2
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- Surgery of gastrointestinal tract (excluding appendectomy)
- History of orthostatic hypotension, fainting spells or blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
Show all 20Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator including study drugs
- History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
- Intake of drugs with a long half-life (> 24 hours) within 1 month or 10 half lives of that drug, whichever is longer, prior to administration of study drugs or during the trial
- Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
- Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within 5 days of study drug administration
- Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
- Smoker
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood or plasma donation (>400 ml) within 1 month prior to administration or during trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Following specific laboratory findings: aspartate aminotransferase, alanine transaminase, Gamma-glutamyl-transferase above the reference range
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: An Open Label, Randomised, Crossover Study of the Bioavailability of Oral BIRB 796 BS Tablets (30 mg Single Dose) With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers to Assess the Effect of Gastric pH on Absorption of BIRB 796 BS.
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.
Safety and tolerability were also assessed.
- Conditions
- Healthy
- Being tested
- BIBR 796 BS, Pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 796 BSDevice
single dose
PantoprazoleDrug
5 days
| Study group | Role | What they receive |
|---|---|---|
| BIBR 796 BS + pantoprazole | Experimental | Not described Receives: Device: BIBR 796 BS; Drug: Pantoprazole |
| BIBR 796 BS without pantoprazole | Active comparator | Not described Receives: Device: BIBR 796 BS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
Measured: up to 36 hours after drug administration
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax)
Measured: up to 36 hours after drug administration
Area under the plasma concentration versus time curve over a given time interval (AUC0-t)
Measured: up to 36 hours after drug administration
Time to the maximum plasma concentration (tmax)
Measured: up to 36 hours after drug administration
Apparent oral clearance (CL/F)
Measured: up to 36 hours after drug administration
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Measured: up to 36 hours after drug administration
Elimination half-life (t1/2)
Measured: up to 36 hours after drug administration
Mean residence time (MRT)
Measured: up to 36 hours after drug administration
Gastric pH measurements
Measured: up to 12 hours after drug administration
Number of patients with adverse events
Measured: up to 34 days
Assessment of tolerability
based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations
Measured: on the last 1 day of second treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startNov 2001
- Primary completionJan 2002
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
- 22 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
- NCT02209831
- Sponsor's protocol ID
- 1175.17
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Crossover Study of the Bioavailability of Oral BIRB 796 BS Tablets (30 mg Single Dose) With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers to Assess the Effect of Gastric pH on Absorption of BIRB 796 BS.
- ClinicalTrials.gov ID
- NCT02209831
- Acronym / sponsor ID
- 1175.17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jan 2002 (actual)
- First posted
- 6 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.
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.
Safety and tolerability were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBR 796 BS + pantoprazole | Experimental | Device: BIBR 796 BS, Drug: Pantoprazole |
| BIBR 796 BS without pantoprazole | Active comparator | Device: BIBR 796 BS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male 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
- Laboratory examinations within a clinically defined reference range
- Helicobacter pylori negative
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- Surgery of gastrointestinal tract (excluding appendectomy)
- History of orthostatic hypotension, fainting spells or blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 |
|---|---|---|
| BIBR 796 BSsingle dose | Device | BIBR 796 BS + pantoprazole, BIBR 796 BS without pantoprazole |
| Pantoprazole5 days | Drug | BIBR 796 BS + pantoprazole |
Primary outcome
Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
Time frame: up to 36 hours after drug administration
10 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: up to 36 hours after drug administration
Area under the plasma concentration versus time curve over a given time interval (AUC0-t)
Time frame: up to 36 hours after drug administration
Time to the maximum plasma concentration (tmax)
Time frame: up to 36 hours after drug administration
Apparent oral clearance (CL/F)
Time frame: up to 36 hours after drug administration
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Time frame: up to 36 hours after drug administration
Elimination half-life (t1/2)
Time frame: up to 36 hours after drug administration
Mean residence time (MRT)
Time frame: up to 36 hours after drug administration
Gastric pH measurements
Time frame: up to 12 hours after drug administration
Number of patients with adverse events
Time frame: up to 34 days
Assessment of tolerability
Time frame: on the last 1 day of second treatment
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 Aug 2014.
- Related InfoLink provided by the sponsor.
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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 BIBR 796 BS and Pantoprazole 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 7 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 6 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 plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.) (time frame: up to 36 hours after drug administration). 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 Aug 2014.