HealthyPhase 1NCT02256761
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers
A Phase 1 study testing BIRT 2584 XX - multiple escalating dose, BIRT 2584 XX - single dose and high caloric meal in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male healthy volunteers and to determine the relative bioavailability of the BIRT 2584 XX tablet formulation compared by… Read more about this study
- Who is it for?
- Ages 18 to 63 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIRT 2584 XX - multiple escalating dose, BIRT 2584 XX - single dose and high caloric meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 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 63 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 ≤ 63 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: Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses of 100 mg to 750 mg qd for 14 or 28 Days (Randomised, Double-blind Placebo Controlled Design), and Safety and Pharmacokinetics of 500 mg of BIRT 2584 XX Administered With and Without Food as Single Dose (Open, Intra-individual Comparison) to Healthy Male Volunteers
The study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male healthy volunteers and to determine the relative bioavailability of the BIRT 2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG 400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT 2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days, or 750 mg qd for 28 days) in healthy male subjects (part 2)
- Conditions
- Healthy
- Being tested
- BIRT 2584 XX - multiple escalating dose, Placebo, BIRT 2584 XX - single dose, high caloric meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRT 2584 XX - multiple escalating doseDrug
PlaceboDrug
BIRT 2584 XX - single doseDrug
high caloric mealOther
30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served
| Study group | Role | What they receive |
|---|---|---|
| BIRT 2584 XX - single dose | Experimental | Part 1 - bioavailability/food effect
two single doses, 30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served Receives: Drug: BIRT 2584 XX - single dose; Other: high caloric meal |
| Placebo | Placebo comparator | Part 2 Receives: Drug: Placebo |
| BIRT 2584 XX - multiple escalating dose | Experimental | Part 2 - multiple escalating dose, 14 days and 28 days Receives: Drug: BIRT 2584 XX - multiple escalating dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal findings in physical examination
Measured: up to 45 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 45 days
Number of subjects with clinically significant changes in vital signs
Pulse rate, systolic, and diastolic blood pressure
Measured: up to 45 days
Number of subjects with adverse events
Measured: up to 59 days
Number of subjects with clinically significant changes in 12-lead ECG
Measured: up to 45 days
Secondary outcomes (21)
AUC0-inf (area under the concentration-time curve of BIRT 2584 XX in plasma over the time interval from 0 to infinity)
bioavailability/food effect part
Measured: up to 72 hours
Cmax (maximum concentration of BIRT 2584 XX in plasma)
bioavailability/food effect part
Measured: up to 72 hours
tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100, its major metabolite in humans)
bioavailability/food effect part
Measured: up to 72 hours
Cmax (maximum concentration of BIRT 2584 XX and BI 610100 in plasma)
multiple rising dose part
Measured: up to 42 days
tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100)
multiple rising dose part
Measured: up to 42 days
AUC0-12 (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma over the time interval from 0 to 12 hours after the first dose
multiple rising dose part
Measured: up to 14 hours after first drug administration
AUCtau,l (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma over a uniform dose interval tau after administration of the last dose)
multiple rising dose part
Measured: up to 42 days
Cmin,ss (minimum concentration of BIRT 2584 XX and BI 610100 in plasma at steady state over a uniform dosing interval tau)
multiple rising dose part
Measured: up to 42 days
AUCtau,ss (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma at steady state over a uniform dosing interval tau)
multiple rising dose part
Measured: up to 42 days
λz,ss (terminal rate constant of BIRT 2584 XX and BI 610100 in plasma at steady state)
multiple rising dose part
Measured: up to 42 days
t1/2,ss (terminal half-life of BIRT 2584 XX and BI 610100 in plasma at steady state)
multiple rising dose part
Measured: up to 42 days
MRTpo,ss (mean residence time of BIRT 2584 XX and BI 610100 in the body at steady state after po administration)
multiple rising dose part
Measured: up to 42 days
CL/F,ss (apparent clearance of BIRT 2584 XX from plasma at steady state after extravascular multiple dose administration)
multiple rising dose part
Measured: up to 42 days
Vz/F,ss (apparent volume of distribution of BIRT XX 2584 during the terminal phase λz at steady state following extravascular administration)
multiple rising dose part
Measured: up to 42 days
Aet1-t2,ss (amount of BIRT 2584 XX and BI 610100 that is eliminated in urine at steady state from the time point t1 to time point t2)
multiple rising dose part
Measured: up to 30 days
fet1-t2,ss (fraction of BIRT 2584 XX and BI 610100 eliminated in urine at steady state from time point t1 to the time point t2)
multiple rising dose part
Measured: up to 30 days
Accumulation ratio of the analyte in plasma at steady state at the end of dosing expressed as a ratio of Cmax after the last dose to Cmax after the first dose (RA,Cmax)
multiple rising dose part
Measured: up to 42 days
Accumulation ratio of the analyte in plasma at steady state at the end of dosing expressed as a ratio of AUCtau after the last dose to AUCtau after the first dose (RA,AUC)
multiple rising dose part
Measured: up to 42 days
Assessment of receptor occupancy
determined by a competitive binding assay using anti-Lymphocyte function associated antigen-1 (LFA-1) antibody fragment as competitor
Measured: up to 42 days
Assessment of ex vivo suppression of superantigen (SEB)-induced Interleukin (IL)-2 production
Measured: up to 42 days
Total number of white blood cells and leukocyte differential cell count
Measured: up to 42 days
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 startJan 2005
- Primary completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 74 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
- NCT02256761
- Sponsor's protocol ID
- 1206.2
- 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
- Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses of 100 mg to 750 mg qd for 14 or 28 Days (Randomised, Double-blind Placebo Controlled Design), and Safety and Pharmacokinetics of 500 mg of BIRT 2584 XX Administered With and Without Food as Single Dose (Open, Intra-individual Comparison) to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02256761
- Acronym / sponsor ID
- 1206.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 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 study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male healthy volunteers and to determine the relative bioavailability of the BIRT 2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG 400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT 2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days, or 750 mg qd for 28 days) in healthy male subjects (part 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIRT 2584 XX - single dose | Experimental | Drug: BIRT 2584 XX - single dose, Other: high caloric mealPart 1 - bioavailability/food effect two single doses, 30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served |
| Placebo | Placebo comparator | Drug: PlaceboPart 2 |
| BIRT 2584 XX - multiple escalating dose | Experimental | Drug: BIRT 2584 XX - multiple escalating dosePart 2 - multiple escalating dose, 14 days and 28 days |
Who may qualify
- Ages
- 18 to 63 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 ≤ 63 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 - multiple escalating dose | Drug | BIRT 2584 XX - multiple escalating dose |
| Placebo | Drug | Placebo |
| BIRT 2584 XX - single dose | Drug | BIRT 2584 XX - single dose |
| high caloric meal30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served | Other | BIRT 2584 XX - single dose |
Primary outcome
Number of subjects with abnormal findings in physical examination
Time frame: up to 45 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 45 days
Number of subjects with clinically significant changes in vital signs
Time frame: up to 45 days
Pulse rate, systolic, and diastolic blood pressure
Number of subjects with adverse events
Time frame: up to 59 days
Number of subjects with clinically significant changes in 12-lead ECG
Time frame: up to 45 days
21 secondary outcomes
AUC0-inf (area under the concentration-time curve of BIRT 2584 XX in plasma over the time interval from 0 to infinity)
Time frame: up to 72 hours
Cmax (maximum concentration of BIRT 2584 XX in plasma)
Time frame: up to 72 hours
tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100, its major metabolite in humans)
Time frame: up to 72 hours
Cmax (maximum concentration of BIRT 2584 XX and BI 610100 in plasma)
Time frame: up to 42 days
tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100)
Time frame: up to 42 days
AUC0-12 (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma over the time interval from 0 to 12 hours after the first dose
Time frame: up to 14 hours after first drug administration
AUCtau,l (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma over a uniform dose interval tau after administration of the last dose)
Time frame: up to 42 days
Cmin,ss (minimum concentration of BIRT 2584 XX and BI 610100 in plasma at steady state over a uniform dosing interval tau)
Time frame: up to 42 days
AUCtau,ss (area under the concentration-time curve of BIRT 2584 XX and BI 610100 in plasma at steady state over a uniform dosing interval tau)
Time frame: up to 42 days
λz,ss (terminal rate constant of BIRT 2584 XX and BI 610100 in plasma at steady state)
Time frame: up to 42 days
t1/2,ss (terminal half-life of BIRT 2584 XX and BI 610100 in plasma at steady state)
Time frame: up to 42 days
MRTpo,ss (mean residence time of BIRT 2584 XX and BI 610100 in the body at steady state after po administration)
Time frame: up to 42 days
CL/F,ss (apparent clearance of BIRT 2584 XX from plasma at steady state after extravascular multiple dose administration)
Time frame: up to 42 days
Vz/F,ss (apparent volume of distribution of BIRT XX 2584 during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 42 days
Aet1-t2,ss (amount of BIRT 2584 XX and BI 610100 that is eliminated in urine at steady state from the time point t1 to time point t2)
Time frame: up to 30 days
fet1-t2,ss (fraction of BIRT 2584 XX and BI 610100 eliminated in urine at steady state from time point t1 to the time point t2)
Time frame: up to 30 days
Accumulation ratio of the analyte in plasma at steady state at the end of dosing expressed as a ratio of Cmax after the last dose to Cmax after the first dose (RA,Cmax)
Time frame: up to 42 days
Accumulation ratio of the analyte in plasma at steady state at the end of dosing expressed as a ratio of AUCtau after the last dose to AUCtau after the first dose (RA,AUC)
Time frame: up to 42 days
Assessment of receptor occupancy
Time frame: up to 42 days
Assessment of ex vivo suppression of superantigen (SEB)-induced Interleukin (IL)-2 production
Time frame: up to 42 days
Total number of white blood cells and leukocyte differential cell count
Time frame: up to 42 days
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 - multiple escalating dose, BIRT 2584 XX - single dose and high caloric meal 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. 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 subjects with abnormal findings in physical examination (time frame: up to 45 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.