HealthyPhase 1NCT01348165
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
A Phase 1 study testing BI 137882 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers 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?
- BI 137882
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 21 to 50 years
- BMI 18.5 to 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
Show all 21Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes /day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 20 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers (A Randomised, Single-blind, Placebo-controlled Phase I Study)
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
Read the detailed description
As a transition from preclinical investigations to clinical development in this first-in-man trial, safety, tolerability, and pharmacokinetics of BI 137882 will be assessed in healthy male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 137882 in the indication of COPD.
Healthy male subjects aged 21 - 50 years will be recruited for this study. They provide a relatively stable physiological, biochemical and hormonal basis (steady state) for studying drug effects, they show no disease-related variation and they are not taking concomitant medication.
Within each dose group, all actively treated individuals will receive the same BI 137882 dose. The next higher dose will only be administered if the treatment in the preceding dose group was safe and well tolerated.
- Conditions
- Healthy
- Being tested
- BI 137882, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 137882Drug
Powder for oral solution
PlaceboDrug
Powder for oral solution
| Study group | Role | What they receive |
|---|---|---|
| BI 137882 Dose 1 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 2 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 3 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 4 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 5 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 6 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 7 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 8 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| BI 137882 Dose 9 | Experimental | Powder for oral solution Receives: Drug: BI 137882 |
| Placebo | Placebo comparator | Powder for oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Drug Related Adverse Events
Number of subjects with drug related adverse events (AEs)
Measured: From baseline up to 28 days
Blood Pressure
Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Measured: Baseline and 28 days
Pulse Rate (PR)
Change from Baseline to 28 Days in Pulse Rate
Measured: Baseline and 28 days
Respiratory Rate (RR)
Change from Baseline to 28 Days in Respiratory rate (RR)
Measured: Baseline and 28 days
Body Temperature
Change from baseline to 28 Days in Body temperature
Measured: Baseline and 28 days
Assessment of Tolerability by Investigator
The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Measured: 28 days
Secondary outcomes (17)
Maximum Measured Concentration (Cmax)
Maximum measured concentration of BI 137882 in plasma.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to maximum measured concentration of the analyte in plasma.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Area Under the Curve 0 to Infinity (AUC0-infinity)
Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Terminal Half-life (t1/2)
Terminal half-life of BI 137882 in plasma.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Terminal Rate Constant (λz)
Terminal rate constant in plasma.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Mean Residence Time (MRTpo)
Mean residence time of the analyte in the body after oral administration.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Apparent Clearance (CL/F)
Apparent clearance of the analyte in plasma after extravascular administration.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Apparent Volume of Distribution (Vz/F)
Apparent volume of distribution of the analyte during the terminal phase.
Measured: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2
Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Measured: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2
Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)
Measured: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2
Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)
Measured: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production.
Measured: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production.
Measured: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration
Area Under the Effect Curve (AUEC)
Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.
Measured: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration
Maximum Effect (Emax)
Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.
Measured: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration
Minimum Effect (Emin)
Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.
Measured: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h 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 posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348165
- Sponsor's protocol ID
- 1306.1
- Other IDs
- 2010-023462-52
- Status last verified
- Aug 2016
- First submitted
- 3 May 2011
- Last updated
- 16 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers (A Randomised, Single-blind, Placebo-controlled Phase I Study)
- ClinicalTrials.gov ID
- NCT01348165
- Acronym / sponsor ID
- 1306.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
Detailed description
As a transition from preclinical investigations to clinical development in this first-in-man trial, safety, tolerability, and pharmacokinetics of BI 137882 will be assessed in healthy male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 137882 in the indication of COPD.
Healthy male subjects aged 21 - 50 years will be recruited for this study. They provide a relatively stable physiological, biochemical and hormonal basis (steady state) for studying drug effects, they show no disease-related variation and they are not taking concomitant medication.
Within each dose group, all actively treated individuals will receive the same BI 137882 dose. The next higher dose will only be administered if the treatment in the preceding dose group was safe and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| BI 137882 Dose 1 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 2 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 3 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 4 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 5 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 6 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 7 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 8 | Experimental | Drug: BI 137882Powder for oral solution |
| BI 137882 Dose 9 | Experimental | Drug: BI 137882Powder for oral solution |
| Placebo | Placebo comparator | Drug: PlaceboPowder for oral solution |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 21 to 50 years
- BMI 18.5 to 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Key exclusion criteria (21 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| BI 137882Powder for oral solution | Drug | BI 137882 Dose 1, BI 137882 Dose 2, BI 137882 Dose 3, BI 137882 Dose 4, BI 137882 Dose 5, BI 137882 Dose 6, BI 137882 Dose 7, BI 137882 Dose 8, BI 137882 Dose 9 |
| PlaceboPowder for oral solution | Drug | Placebo |
Primary outcome
Number of Subjects With Drug Related Adverse Events
Time frame: From baseline up to 28 days
Number of subjects with drug related adverse events (AEs)
Blood Pressure
Time frame: Baseline and 28 days
Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Pulse Rate (PR)
Time frame: Baseline and 28 days
Change from Baseline to 28 Days in Pulse Rate
Respiratory Rate (RR)
Time frame: Baseline and 28 days
Change from Baseline to 28 Days in Respiratory rate (RR)
Body Temperature
Time frame: Baseline and 28 days
Change from baseline to 28 Days in Body temperature
Assessment of Tolerability by Investigator
Time frame: 28 days
The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
17 secondary outcomes
Maximum Measured Concentration (Cmax)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Area Under the Curve 0 to Infinity (AUC0-infinity)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Terminal Half-life (t1/2)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Terminal Rate Constant (λz)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Mean Residence Time (MRTpo)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Apparent Clearance (CL/F)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Apparent Volume of Distribution (Vz/F)
Time frame: 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration
Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2
Time frame: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2
Time frame: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2
Time frame: 0-4, 4-8, 8-12, and 12-24 hours after drug administration
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
Time frame: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
Time frame: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration
Area Under the Effect Curve (AUEC)
Time frame: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration
Maximum Effect (Emax)
Time frame: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration
Minimum Effect (Emin)
Time frame: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 137882 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 21 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 16 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Drug Related Adverse Events (time frame: From baseline up to 28 days). The study lists 6 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 16 Sep 2016.