HealthyPhase 1NCT02268760
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
A Phase 1 study testing BILN 2061 ZW single rising doses, BILN 2061 ZW fixed dose and Standardized breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW 1. In rising single doses 2. With and without a 64 g fat breakfast at one selected dose 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?
- BILN 2061 ZW single rising doses, BILN 2061 ZW fixed dose and Standardized breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Sep 2001
- 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
- Broca ≥ - 20 % and ≤ + 20 %
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the clinically accepted reference range and of clinical relevance
- History of any familial bleeding disorder
About this study
Official title: Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400: Ethanol Solution) in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part)
To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW
- In rising single doses
- With and without a 64 g fat breakfast at one selected dose
- Conditions
- Healthy
- Being tested
- BILN 2061 ZW single rising doses, Placebo, BILN 2061 ZW fixed dose, Standardized breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILN 2061 ZW single rising dosesDrug
PlaceboDrug
BILN 2061 ZW fixed doseDrug
Standardized breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| BILN 2061 ZW single rising doses | Experimental | Not described Receives: Drug: BILN 2061 ZW single rising doses |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BILN 2061 ZW fixed dose fed | Experimental | Not described Receives: Drug: BILN 2061 ZW fixed dose; Other: Standardized breakfast |
| BILN 2061 ZW fixed dose fasted | Active comparator | Not described Receives: Drug: BILN 2061 ZW fixed dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate)
Measured: Pre-dose, up to 48 hours after drug administration
Changes from baseline in laboratory tests
Measured: Pre-dose and 48 hours after drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Measured: Pre-dose, up to 48 hours after drug administration
Changes from baseline in physical examination
Measured: Pre-dose and 48 hours after drug administration
Number of patients with adverse events
Measured: Up to 48 hours after drug administration
Global assessment of tolerability by the investigator on a 4-point scale
Measured: Up to 48 hours after drug administration
Maximum concentration of the analyte in plasma after a single dose administration (Cmax)
Measured: up to 48 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity)
Measured: up to 48 hours after drug administration
Time to reach Cmax following a single dose administration (tmax)
Measured: up to 48 hours after drug administration
Elimination half-life of the analyte in plasma (t1/2)
Measured: up to 48 hours after drug administration
Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F)
Measured: up to 48 hours after drug administration
Total mean residence time of the analyte in plasma (MRT)
Measured: up to 48 hours after drug administration
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Measured: up to 48 hours after drug administration
Amount of intact drug excreted in urine (Au)
Measured: up to 48 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 posted20 Oct 2014 (estimated)
- Study startJun 2001
- Primary completionSep 2001
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
- 103 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
- NCT02268760
- Sponsor's protocol ID
- 605.1
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400: Ethanol Solution) in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part)
- ClinicalTrials.gov ID
- NCT02268760
- Acronym / sponsor ID
- 605.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Sep 2001 (actual)
- First posted
- 20 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 the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW
- In rising single doses
- With and without a 64 g fat breakfast at one selected dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BILN 2061 ZW single rising doses | Experimental | Drug: BILN 2061 ZW single rising doses |
| Placebo | Placebo comparator | Drug: Placebo |
| BILN 2061 ZW fixed dose fed | Experimental | Drug: BILN 2061 ZW fixed dose, Other: Standardized breakfast |
| BILN 2061 ZW fixed dose fasted | Active comparator | Drug: BILN 2061 ZW fixed dose |
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
- Broca ≥ - 20 % and ≤ + 20 %
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
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 |
|---|---|---|
| BILN 2061 ZW single rising doses | Drug | BILN 2061 ZW single rising doses |
| Placebo | Drug | Placebo |
| BILN 2061 ZW fixed dose | Drug | BILN 2061 ZW fixed dose fasted, BILN 2061 ZW fixed dose fed |
| Standardized breakfast | Other | BILN 2061 ZW fixed dose fed |
Primary outcome
Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate)
Time frame: Pre-dose, up to 48 hours after drug administration
Changes from baseline in laboratory tests
Time frame: Pre-dose and 48 hours after drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 48 hours after drug administration
Changes from baseline in physical examination
Time frame: Pre-dose and 48 hours after drug administration
Number of patients with adverse events
Time frame: Up to 48 hours after drug administration
Global assessment of tolerability by the investigator on a 4-point scale
Time frame: Up to 48 hours after drug administration
Maximum concentration of the analyte in plasma after a single dose administration (Cmax)
Time frame: up to 48 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity)
Time frame: up to 48 hours after drug administration
Time to reach Cmax following a single dose administration (tmax)
Time frame: up to 48 hours after drug administration
Elimination half-life of the analyte in plasma (t1/2)
Time frame: up to 48 hours after drug administration
Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F)
Time frame: up to 48 hours after drug administration
Total mean residence time of the analyte in plasma (MRT)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: up to 48 hours after drug administration
Amount of intact drug excreted in urine (Au)
Time frame: up to 48 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 20 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 BILN 2061 ZW single rising doses, BILN 2061 ZW fixed dose and Standardized breakfast 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 16 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 20 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 patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate) (time frame: Pre-dose, up to 48 hours after drug administration). The study lists 14 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 20 Oct 2014.