HealthyPhase 1NCT02254538
A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers
A Phase 1 study testing BILR 355 BS and PEG 400 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BILR 355 BS and PEG 400
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Feb 2003
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).
- In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- 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 18Show fewer
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
- Following exclusion criteria are of special interest for this study:
- Erythema, exanthema and comparable skin alterations
About this study
Official title: A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS
- Conditions
- Healthy
- Being tested
- BILR 355 BS, PEG 400
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 BSDrug
PEG 400Drug
| Study group | Role | What they receive |
|---|---|---|
| BILR 355 BS | Experimental | escalating doses Receives: Drug: BILR 355 BS; Drug: PEG 400 |
| Placebo | Placebo comparator | Not described Receives: Drug: PEG 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically significant changes in vital functions
Measured: Up to 10 days after drug administration
Number of participants with abnormal findings in ECG (electrocardiogram)
Measured: Up to 10 days after drug administration
Number of participants with abnormal findings in skin inspections
Measured: Up to 10 days after drug administration
Number of participants with abnormal neurological finding
Measured: Up to 10 days after drug administration
Number of participants with abnormal changes in laboratory parameters
Measured: Up to 10 days after drug administration
Number of participants with positive faecal occult blood testing
Measured: Up to 10 days after drug administration
Number of participants with adverse events
Measured: Up to 10 days after drug administration
Secondary outcomes (10)
Maximum plasma concentration (Cmax)
Measured: Up to 144 hours after drug administration
Time to attain maximum plasma concentration (tmax)
Measured: Up to 144 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
Measured: Up to 144 hours after drug administration
Terminal half life (t½)
Measured: Up to 144 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: Up to 144 hours after drug administration
Total mean residence time (MRTtot)
Measured: Up to 144 hours after drug administration
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Measured: Up to 144 hours after drug administration
Renal clearance of the analyte (CLR)
Measured: Up to 72 hours after drug administration
Amount of drug excreted in the urine (Ae)
Measured: Up to 72 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Measured: Up to 144 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 posted2 Oct 2014 (estimated)
- Study startMay 2002
- Primary completionFeb 2003
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
- 54 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
- NCT02254538
- Sponsor's protocol ID
- 1188.1
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)
- ClinicalTrials.gov ID
- NCT02254538
- Acronym / sponsor ID
- 1188.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Feb 2003 (actual)
- First posted
- 2 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.
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BILR 355 BS | Experimental | Drug: BILR 355 BS, Drug: PEG 400escalating doses |
| Placebo | Placebo comparator | Drug: PEG 400 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).
- In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Key exclusion criteria (18 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- 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 |
|---|---|---|
| BILR 355 BS | Drug | BILR 355 BS |
| PEG 400 | Drug | BILR 355 BS, Placebo |
Primary outcome
Number of participants with clinically significant changes in vital functions
Time frame: Up to 10 days after drug administration
Number of participants with abnormal findings in ECG (electrocardiogram)
Time frame: Up to 10 days after drug administration
Number of participants with abnormal findings in skin inspections
Time frame: Up to 10 days after drug administration
Number of participants with abnormal neurological finding
Time frame: Up to 10 days after drug administration
Number of participants with abnormal changes in laboratory parameters
Time frame: Up to 10 days after drug administration
Number of participants with positive faecal occult blood testing
Time frame: Up to 10 days after drug administration
Number of participants with adverse events
Time frame: Up to 10 days after drug administration
10 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Up to 144 hours after drug administration
Time to attain maximum plasma concentration (tmax)
Time frame: Up to 144 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
Time frame: Up to 144 hours after drug administration
Terminal half life (t½)
Time frame: Up to 144 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 144 hours after drug administration
Total mean residence time (MRTtot)
Time frame: Up to 144 hours after drug administration
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Up to 144 hours after drug administration
Renal clearance of the analyte (CLR)
Time frame: Up to 72 hours after drug administration
Amount of drug excreted in the urine (Ae)
Time frame: Up to 72 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Time frame: Up to 144 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 2 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 BILR 355 BS and PEG 400 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 2 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 2 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 clinically significant changes in vital functions (time frame: Up to 10 days after drug administration). The study lists 7 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 2 Oct 2014.