HealthyPhase 1NCT02224079
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
A Phase 1 study testing BIIB 722 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL 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?
- BIIB 722 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jun 2002
- 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
- Healthy males
- 21 to 50 years of age
- Broca index >= -20% and <= +20%
- Written informed consent according to Good Clinical Practice (GCP) and local legislation
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Diseases of the central nervous system 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 16Show 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
- Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial
- Participation in another trial with an investigational drug (<= two months prior to administration or during trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
About this study
Official title: Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
- Conditions
- Healthy
- Being tested
- BIIB 722 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB 722 CLDrug
PlaceboDrug
Hydroxypropyl-beta-cyclodextrin (HPβCD)
| Study group | Role | What they receive |
|---|---|---|
| BIIB 722 CL | Experimental | Not described Receives: Drug: BIIB 722 CL; Drug: Placebo |
| 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 subjects with adverse events
Measured: up to 12 days after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate, respiratory rate, oral body temperature
Measured: up to 12 days after drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 12 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 12 days after drug administration
Secondary outcomes (9)
Plasma concentration time profiles
Measured: up to 96 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 96 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)
Measured: up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 96 hours after drug administration
Mean residence time of the analyte in the body (MRT)
Measured: up to 96 hours after drug administration
Total clearance of the analyte in plasma (CL)
Measured: up to 96 hours after drug administration
Apparent volume of distribution at steady state (Vss)
Measured: up to 96 hours after drug administration
Amount of drug excreted into urine (Ae)
Measured: up to 72 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 posted25 Aug 2014 (estimated)
- Study startApr 2002
- Primary completionJun 2002
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
- Single blind
- Enrolment
- 100 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
- NCT02224079
- Sponsor's protocol ID
- 1180.3
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.
- ClinicalTrials.gov ID
- NCT02224079
- Acronym / sponsor ID
- 1180.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Jun 2002 (actual)
- First posted
- 25 Aug 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.
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB 722 CL | Experimental | Drug: BIIB 722 CL, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- 21 to 50 years of age
- Broca index >= -20% and <= +20%
- Written informed consent according to Good Clinical Practice (GCP) and local legislation
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Diseases of the central nervous system 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 |
|---|---|---|
| BIIB 722 CL | Drug | BIIB 722 CL |
| PlaceboHydroxypropyl-beta-cyclodextrin (HPβCD) | Drug | BIIB 722 CL, Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 12 days after drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 12 days after drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant findings in ECG
Time frame: up to 12 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 12 days after drug administration
9 secondary outcomes
Plasma concentration time profiles
Time frame: up to 96 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)
Time frame: up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 96 hours after drug administration
Mean residence time of the analyte in the body (MRT)
Time frame: up to 96 hours after drug administration
Total clearance of the analyte in plasma (CL)
Time frame: up to 96 hours after drug administration
Apparent volume of distribution at steady state (Vss)
Time frame: up to 96 hours after drug administration
Amount of drug excreted into urine (Ae)
Time frame: up to 72 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 25 Aug 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 BIIB 722 CL 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 25 Aug 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 adverse events (time frame: up to 12 days after drug administration). The study lists 4 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 25 Aug 2014.