HealthyPhase 1NCT02259894
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
A Phase 1 study testing BIRT 2584 XX in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects 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?
- BIRT 2584 XX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jun 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 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 <=50 years
- 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, haematological, 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 18Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 study drug administration or expected during the trial)
- Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
- Clinically relevant laboratory abnormalities
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QT interval, Bazett correction (QTcB) > 450 ms or QT interval >500 ms
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: Safety, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a Solution in PEG 400 Administered to Healthy Male Volunteers. Placebo Controlled and Blinded at Each Dose Level.
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects
- Conditions
- Healthy
- Being tested
- BIRT 2584 XX, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRT 2584 XXDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIRT 2584 | Experimental | single rising doses Receives: Drug: BIRT 2584 XX |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 16 days after drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to 16 days after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to 16 days after drug administration
Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)
Measured: Up to 16 days after drug administration
Number of participants with abnormal findings in physical examination
Measured: Screening and up to 16 days after drug administration
Secondary outcomes (14)
Cmax (maximum concentration in plasma)
Measured: Up to 360 hours after drug administration
tmax (time from dosing to maximum concentration)
Measured: Up to 360 hours after 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 360 hours after 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 analyte plasma concentration)
Measured: Up to 360 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 360 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 360 hours after drug administration
MRT(mean residence time of the analyte in the body)
Measured: Up to 360 hours after drug administration
CL/F (apparent oral clearance in plasma after oral administration)
Measured: Up to 360 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz) dose)
Measured: Up to 360 hours after drug administration
Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)
Measured: Up to 48 hours after drug administration
fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)
Measured: Up to 48 hours after drug administration
CLR,0-48 (renal clearance of the analyte from 0-48 hours)
Measured: Up to 48 hours after drug administration
Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)
Measured: Up to 360 hours after drug administration
Inhibition of IL-2 production
in response to superantigen challenge ex vivo
Measured: Up to 360 hours 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 posted9 Oct 2014 (estimated)
- Study startMar 2004
- Primary completionJun 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
- 55 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
- NCT02259894
- Sponsor's protocol ID
- 1206.1
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a Solution in PEG 400 Administered to Healthy Male Volunteers. Placebo Controlled and Blinded at Each Dose Level.
- ClinicalTrials.gov ID
- NCT02259894
- Acronym / sponsor ID
- 1206.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jun 2004 (actual)
- First posted
- 9 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.
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIRT 2584 | Experimental | Drug: BIRT 2584 XXsingle rising doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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 <=50 years
- BMI >=18.5 and <=29.9 kg/m2
Key exclusion criteria (18 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, haematological, 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 |
| Placebo | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to 16 days after drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to 16 days after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 16 days after drug administration
Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)
Time frame: Up to 16 days after drug administration
Number of participants with abnormal findings in physical examination
Time frame: Screening and up to 16 days after drug administration
14 secondary outcomes
Cmax (maximum concentration in plasma)
Time frame: Up to 360 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: Up to 360 hours after 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 360 hours after 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 analyte plasma concentration)
Time frame: Up to 360 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 360 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 360 hours after drug administration
MRT(mean residence time of the analyte in the body)
Time frame: Up to 360 hours after drug administration
CL/F (apparent oral clearance in plasma after oral administration)
Time frame: Up to 360 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz) dose)
Time frame: Up to 360 hours after drug administration
Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)
Time frame: Up to 48 hours after drug administration
fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)
Time frame: Up to 48 hours after drug administration
CLR,0-48 (renal clearance of the analyte from 0-48 hours)
Time frame: Up to 48 hours after drug administration
Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)
Time frame: Up to 360 hours after drug administration
Inhibition of IL-2 production
Time frame: Up to 360 hours 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 9 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 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 9 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 participants with adverse events (time frame: Up to 16 days after drug administration). 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 9 Oct 2014.