HealthyPhase 1NCT02256748
Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers
A Phase 1 study testing BIRT 2584 XX and Midazolam in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for CYP3A4. 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?
- BIRT 2584 XX and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Aug 2005
- 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 the screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Who cannot join
- Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
Show all 15Show fewer
- History of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (greater than 24 hours) (less than 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
- Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)
- Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)
- Alcohol abuse (more than 60 g of ethanol per day)
- Drug abuse
- Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)
- Clinically relevant laboratory abnormalities
About this study
Official title: A Study to Evaluate the Effect of Multiple Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers
The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRT 2584 XXDrug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| BIRT 2584 XX + Midazolam | Experimental | BIRT 2584 XX: Multiple doses for 12 days (bid on days 1 and 2, qd from days 3 to 12)
Midazolam: Administration on days -2, 1, 3, and 12 Receives: Drug: BIRT 2584 XX; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ of midazolam (area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 13 days
Cmax of midazolam (maximum concentration of midazolam in plasma)
Measured: up to 13 days
AUC0-∞ of 1'-hydroxymidazolam (area under the concentration-time curve of 1'-hydroxymidazolam in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 13 days
Cmax of 1'-hydroxymidazolam (maximum concentration of 1'-hydroxymidazolam in plasma)
Measured: up to 13 days
AUC0-∞ ratio of 1'-hydroxymidazolam to midazolam
Measured: up to 13 days
Secondary outcomes (14)
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 13 days
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Measured: up to 13 days
λz (terminal rate constant of the analytes in plasma)
Measured: up to 13 days
t1/2 (terminal half-life of the analytes in plasma)
Measured: up to 13 days
MRTpo (mean residence time of the analytes in the body after po administration)
Measured: up to 13 days
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Measured: up to 13 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Measured: up to 13 days
Pre-dose levels of BIRT 2584 XX and BI 610100
Measured: days 1, 3 and 12
Number of subjects with abnormal findings in physical examination
Measured: up to 29 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 29 days
Number of subjects with clinically significant changes in 12-lead ECG
Measured: up to 29 days
Number of subjects with clinically significant changes in vital signs
Pulse rate, systolic, and diastolic blood pressure
Measured: up to 29 days
Number of subjects with adverse events
Measured: up to 44 days
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 29
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 startJun 2005
- Primary completionAug 2005
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02256748
- Sponsor's protocol ID
- 1206.9
- 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
- A Study to Evaluate the Effect of Multiple Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02256748
- Acronym / sponsor ID
- 1206.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2005 (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 study was to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIRT 2584 XX + Midazolam | Experimental | Drug: BIRT 2584 XX, Drug: MidazolamBIRT 2584 XX: Multiple doses for 12 days (bid on days 1 and 2, qd from days 3 to 12) Midazolam: Administration on days -2, 1, 3, and 12 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of the screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Key exclusion criteria (15 listed)
- Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells, or blackouts
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 |
|---|---|---|
| BIRT 2584 XX | Drug | BIRT 2584 XX + Midazolam |
| Midazolam | Drug | BIRT 2584 XX + Midazolam |
Primary outcome
AUC0-∞ of midazolam (area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 13 days
Cmax of midazolam (maximum concentration of midazolam in plasma)
Time frame: up to 13 days
AUC0-∞ of 1'-hydroxymidazolam (area under the concentration-time curve of 1'-hydroxymidazolam in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 13 days
Cmax of 1'-hydroxymidazolam (maximum concentration of 1'-hydroxymidazolam in plasma)
Time frame: up to 13 days
AUC0-∞ ratio of 1'-hydroxymidazolam to midazolam
Time frame: up to 13 days
14 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 13 days
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 13 days
λz (terminal rate constant of the analytes in plasma)
Time frame: up to 13 days
t1/2 (terminal half-life of the analytes in plasma)
Time frame: up to 13 days
MRTpo (mean residence time of the analytes in the body after po administration)
Time frame: up to 13 days
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 13 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Time frame: up to 13 days
Pre-dose levels of BIRT 2584 XX and BI 610100
Time frame: days 1, 3 and 12
Number of subjects with abnormal findings in physical examination
Time frame: up to 29 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 29 days
Number of subjects with clinically significant changes in 12-lead ECG
Time frame: up to 29 days
Number of subjects with clinically significant changes in vital signs
Time frame: up to 29 days
Number of subjects with adverse events
Time frame: up to 44 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 29
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 BIRT 2584 XX and Midazolam 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 15 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. 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?
AUC0-∞ of midazolam (area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 13 days). The study lists 5 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; AzTrials last refreshed its copy on 6 Nov 2026.