HealthyPhase 1NCT02227030
Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects
A Phase 1 study testing BIIB 722 CL solution and BIIB 722 CL tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB 722 CL solution and BIIB 722 CL tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Sep 2000
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- 18 to 55 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, hormonal disorders
- History of orthostatic hypotension, fainting spells or 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 15Show 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 2 months prior to administration or during trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol abuse (> 60g/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
About this study
Official title: Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
- Conditions
- Healthy
- Being tested
- BIIB 722 CL solution, BIIB 722 CL tablet, Placebo solution, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB 722 CL solutionDrug
BIIB 722 CL tabletDrug
Placebo solutionDrug
Placebo tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIB 722 CL single rising dose | Experimental | Not described Receives: Drug: BIIB 722 CL solution |
| BIIB 722 CL cross over | Experimental | Not described Receives: Drug: BIIB 722 CL solution; Drug: BIIB 722 CL tablet |
| Placebo solution | Placebo comparator | Not described Receives: Drug: Placebo solution |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma (AUC)
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
Total mean residence time of the analyte in the body (MRTtot)
Measured: up to 96 hours after drug administration
Total clearance of the analyte in plasma (CLtot/f)
Measured: up to 96 hours after drug administration
Secondary outcomes (4)
Number of subjects with adverse events
Measured: up to 96 hours after drug administration
Number of subjects with clinically significant findings in vital functions
Measured: up to 96 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 96 hours after drug administration
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
Measured: up to 24 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 posted27 Aug 2014 (estimated)
- Study startApr 2000
- Primary completionSep 2000
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
- Crossover
- Masking
- Double blind
- Enrolment
- 71 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
- NCT02227030
- Sponsor's protocol ID
- 1180.1
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.
- ClinicalTrials.gov ID
- NCT02227030
- Acronym / sponsor ID
- 1180.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Sep 2000 (actual)
- First posted
- 27 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.
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIIB 722 CL single rising dose | Experimental | Drug: BIIB 722 CL solution |
| BIIB 722 CL cross over | Experimental | Drug: BIIB 722 CL solution, Drug: BIIB 722 CL tablet |
| Placebo solution | Placebo comparator | Drug: Placebo solution |
| Placebo tablet | Placebo comparator | Drug: Placebo tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- 18 to 55 years of age
- Broca index >= -20% and <= +20%
- Written informed consent according to Good Clinical Practice (GCP) and local legislation
Key exclusion criteria (15 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, hormonal disorders
- History of orthostatic hypotension, fainting spells or 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 |
|---|---|---|
| BIIB 722 CL solution | Drug | BIIB 722 CL cross over, BIIB 722 CL single rising dose |
| BIIB 722 CL tablet | Drug | BIIB 722 CL cross over |
| Placebo solution | Drug | Placebo solution |
| Placebo tablet | Drug | Placebo tablet |
Primary outcome
Area under the concentration-time curve of the analyte in plasma (AUC)
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
Total mean residence time of the analyte in the body (MRTtot)
Time frame: up to 96 hours after drug administration
Total clearance of the analyte in plasma (CLtot/f)
Time frame: up to 96 hours after drug administration
4 secondary outcomes
Number of subjects with adverse events
Time frame: up to 96 hours after drug administration
Number of subjects with clinically significant findings in vital functions
Time frame: up to 96 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 96 hours after drug administration
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
Time frame: up to 24 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 27 Aug 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 solution and BIIB 722 CL tablet 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 27 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?
Area under the concentration-time curve of the analyte in plasma (AUC) (time frame: up to 96 hours 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 27 Aug 2014.