HealthyPhase 1NCT02268604
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers
A Phase 1 study testing BIIB 722 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess safety, pharmacodynamics and pharmacokinetics 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 2010
- 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 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 of during trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study 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
About this study
Official title: Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.
Study to assess safety, pharmacodynamics and pharmacokinetics 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
| Study group | Role | What they receive |
|---|---|---|
| BIIB 722 CL | Experimental | Not described Receives: Drug: BIIB 722 CL |
| 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.
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: up to day 7
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to day 7
Time to maximum measured concentration of the analyte in plasma (tmax)
Measured: up to day 7
Total mean residence time of the analyte in the body (MRTtot)
Measured: up to day 7
Total clearance of the analyte in plasma (CLtot/f)
Measured: up to day 7
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to day 7
Amount of the analyte excreted in urine (Ae)
Measured: up to day 7
Dose proportionality
assessed by AUC
Measured: up to day 7
Accumulation factor
(predose concentration/concentration after 8 hours)
Measured: up to day 7
Time to reach steady state
Measured: up to day 7
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
in vitro fluorescence
Measured: up to day 7
Secondary outcomes (3)
Number of subjects with adverse events
Measured: up to day 12
Number of subjects with clinically significant findings in vital functions
Measured: up to day 12
Number of subjects with clinically significant findings in laboratory tests
Measured: up to day 12
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 startOct 2010
- Primary completionOct 2010
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
- 10 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
- NCT02268604
- Sponsor's protocol ID
- 1180.2
- Status last verified
- Oct 2014
- First submitted
- 21 Aug 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, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.
- ClinicalTrials.gov ID
- NCT02268604
- Acronym / sponsor ID
- 1180.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (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.
Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB 722 CL | Experimental | Drug: BIIB 722 CL |
| Placebo | Placebo comparator | Drug: Placebo |
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 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 | Drug | BIIB 722 CL |
| Placebo | Drug | Placebo |
Primary outcome
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to day 7
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to day 7
Time to maximum measured concentration of the analyte in plasma (tmax)
Time frame: up to day 7
Total mean residence time of the analyte in the body (MRTtot)
Time frame: up to day 7
Total clearance of the analyte in plasma (CLtot/f)
Time frame: up to day 7
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to day 7
Amount of the analyte excreted in urine (Ae)
Time frame: up to day 7
Dose proportionality
Time frame: up to day 7
assessed by AUC
Accumulation factor
Time frame: up to day 7
(predose concentration/concentration after 8 hours)
Time to reach steady state
Time frame: up to day 7
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
Time frame: up to day 7
in vitro fluorescence
3 secondary outcomes
Number of subjects with adverse events
Time frame: up to day 12
Number of subjects with clinically significant findings in vital functions
Time frame: up to day 12
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to day 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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 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: stopped early, 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 was stopped early. Results are not available in the source record.
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 day 7). The study lists 11 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.