Healthy Male SubjectsPhase 1NCT03739541
Benznidazole Absorption, Metabolism and Excretion Study
A Phase 1 study testing [14C]-Benznidazole in people with Healthy Male Subjects, run by Exeltis France at 1 site in United Kingdom.
Trial summary
This Phase I ADME study will be conducted to evaluate the pharmacokinetics of benznidazole. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- [14C]-Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 2 Sep 2018
- 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 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males of any race, between 35 and 65 years of age, inclusive, at screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at screening or check-in as assessed by the Investigator (or designee).
- Will agree to use contraception as detailed in Section 7.6.
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and willing to sign an Inform Consent Form and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of dermatological conditions within the 6 months prior to dosing, such as rash, pruritus, and dermatitis, as determined by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is acceptable.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Alcohol consumption of >28 units per week for males. One unit of alcohol equals
Show all 22Show fewer
- ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test or positive urine cotinine test result, or positive urine drug screen (confirmed by repeat) at screening or check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 3).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable per Investigator (or designee) and Sponsor decision.
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable per Investigator (or designee) and Sponsor decision.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating BNZ, and have previously received the investigational product.
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Subjects who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to check-in.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Study of the Absorption, Metabolism and Excretion, of [14C]-Benznidazole (BNZ) Following a Single Oral Dose in Healthy Male Subjects
This Phase I ADME study will be conducted to evaluate the pharmacokinetics of benznidazole.
Read the detailed description
This will be a single-site, open-label, non-randomized, single oral dose absorption, metabolism and excretion study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to dosing on Day 1. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. Subjects will be confined to the CRU until at least Day 11 (240 hours postdose), and will be discharged from the CRU on Day 11 if all the following discharge criteria are met: >90% mass balance recovery; OR plasma/blood radioactivity levels below the limit of quantitation for 2 consecutive collections; and <1% of the total radioactive dose recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods. If these criteria are not met by Day 11, subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day 15 to continue 24-hour blood, urine and faeces collections for the analysis of total radioactivity, unless otherwise agreed upon by the Sponsor and Investigator. If the discharge criteria are not met by Day 15, subjects may be asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24-hour nonresidential collections will occur on Day 21 (±1 day) and Day 28 (±1 day). If on the second occasion the subject has still not met the desired criterion, then the subject will be discharged from the study, per Investigator and Sponsor decision. Pharmacokinetic samples and radioanalytical samples will be obtained through at least 240 hours postdose, and possibly up to 4 weeks postdose (radioanalytical samples only), in case of not meeting discharge criteria. Samples for metabolite profiling/identification will be obtained through 240 hours postdose.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C]-Benznidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BenznidazoleDrug
Also called BNZ
A single dose level of 100 mg; 200 μCi (7.4 MBq)
| Study group | Role | What they receive |
|---|---|---|
| [14C]-Benznidazole | Experimental | A single dose of 100 mg [14C]-BNZ, orally administered on Day 1 following an overnight fast. Receives: Drug: [14C]-Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of BNZ in plasma
maximum observed concentration (Cmax) in plasma
Measured: Days 1-29
Mass balance of [14C]-BNZ
Mass balance of [14C]-BNZ in urine and faeces
Measured: Days 1-29
Chemical structure of [14C]-BNZ metabolites
Characterization of the chemical structure and identification of metabolites of [14C]-BNZ in plasma, urine, and faeces
Measured: Days 1-29
tmax of BNZ in plasma
time to maximum concentration (tmax) in plasma
Measured: Days 1-29
AUC0-t of BNZ in plasma
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in plasma
Measured: Days 1-29
AUC0-∞ of BNZ in plasma
AUC from time zero to infinity (AUC0-∞) in plasma
Measured: Days 1-29
% AUC extrap of BNZ in plasma
percentage extrapolation (% AUCextrap) in plasma
Measured: Days 1-29
t1/2 of BNZ in plasma
apparent terminal elimination half-life (t1/2) in plasma
Measured: Days 1-29
CL/Fof BNZ in plasma
apparent oral clearance (CL/F) in plasma
Measured: Days 1-29
Vz/F of BNZ in plasma
volume of distribution during the elimination phase for BNZ (Vz/F) in plasma
Measured: Days 1-29
Cmax of [14C]-BNZ in plasma
maximum observed concentration (Cmax) in plasma
Measured: Days 1-29
tmax of [14C]-BNZ in plasma
time to maximum concentration (tmax) in plasma
Measured: Days 1-29
AUC0-t of [14C]-BNZ in plasma
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in plasma
Measured: Days 1-29
AUC0-∞ of [14C]-BNZ in plasma
AUC from time zero to infinity (AUC0-∞) in plasma
Measured: Days 1-29
% AUC extrap of [14C]-BNZ in plasma
percentage extrapolation (% AUCextrap) in plasma
Measured: Days 1-29
t1/2 of [14C]-BNZ in plasma
apparent terminal elimination half-life (t1/2) in plasma
Measured: Days 1-29
Cmax of [14C]-BNZ in whole blood
maximum observed concentration (Cmax) in whole blood
Measured: Days 1-29
tmax of [14C]-BNZ in whole blood
time to maximum concentration (tmax) in whole blood
Measured: Days 1-29
AUC0-t of [14C]-BNZ in whole blood
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in whole blood
Measured: Days 1-29
AUC0-∞ of [14C]-BNZ in whole blood
AUC from time zero to infinity (AUC0-∞) in whole blood
Measured: Days 1-29
% AUCextrap of [14C]-BNZ in whole blood
percentage extrapolation (% AUCextrap) in whole blood
Measured: Days 1-29
t1/2 of [14C]-BNZ in whole blood
apparent terminal elimination half-life (t1/2) in whole blood
Measured: Days 1-29
Total radioactivity AUC ratio
Total radioactivity AUC ratio (blood/plasma)
Measured: Days 1-29
Secondary outcomes (17)
The incidence and severity of Adverse Events (AEs)
The incidence of AEs will be presented by severity and by association with the study drug as determined by the Investigator (or designee).
Measured: Days 1-29
The incidence of laboratory abnormalities (haematology)
The incidence of laboratory abnormalities will be measured based on haematology test result.
Measured: Days 1-29
The incidence of laboratory abnormalities (clinical chemistry)
The incidence of laboratory abnormalities will be measured based on clinical chemistry test result.
Measured: Days 1-29
The incidence of laboratory abnormalities (urinalysis)
The incidence of laboratory abnormalities will be measured based on urinalysis test result.
Measured: Days 1-29
Measurement of QT interval (QTcB)
Measure of 12-lead electrocardiogram (ECG); QT interval calculated using the Bazett correction (QTcB) in millisecond
Measured: Days 1-29
Measurement of QT interval (QTcF)
Measure of 12-lead electrocardiogram (ECG); QT interval calculated using the Fridericia correction (QTcF) in millisecond
Measured: Days 1-29
Measurement of PR intervals
Measure of 12-lead electrocardiogram (ECG); PR intervals in millisecond.
Measured: Days 1-29
Measurement of QT intervals
Measure of 12-lead electrocardiogram (ECG); QT intervals in millisecond
Measured: Days 1-29
Measurement of QRS duration
Measure of 12-lead electrocardiogram (ECG); QRS duration in millisecond
Measured: Days 1-29
Measurement of RR
Measure of 12-lead electrocardiogram (ECG); RR in millisecond
Measured: Days 1-29
Measurement of heart rate
Measure of 12-lead electrocardiogram (ECG); heart rate in beats per minute (BPM)
Measured: Days 1-29
Measurement of blood pressure
Measure of supine systolic and diastolic blood pressure ( both in mmHg)
Measured: Days 1-29
Measurement of Physical Examination
Weight (in kilograms) and Height (in centimeters) will be measured
Measured: Days 1-29
Measurement of supine pulse rate
supine pulse rate (in beats/minute)
Measured: Days 1-29
Measurement body temperature
oral body temperature (in Degree Celsius)
Measured: Days 1-29
Measurement of Weight
weight (in kilograms)
Measured: Days 1-29
Measurement of Height
height (in centimeters) w
Measured: Days 1-29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start16 Jul 2018
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exeltis France
- Collaborators
- Insud Pharma
- Responsible party
- Sponsor
- Investigators
- Sunu Valasseri, MBBS, MSc, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739541
- Sponsor's protocol ID
- LPRI747-103
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Study of the Absorption, Metabolism and Excretion, of [14C]-Benznidazole (BNZ) Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03739541
- Acronym / sponsor ID
- LPRI747-103
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Exeltis France
- Collaborators
- Insud Pharma
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- 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.
This Phase I ADME study will be conducted to evaluate the pharmacokinetics of benznidazole.
Detailed description
This will be a single-site, open-label, non-randomized, single oral dose absorption, metabolism and excretion study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to dosing on Day 1. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. Subjects will be confined to the CRU until at least Day 11 (240 hours postdose), and will be discharged from the CRU on Day 11 if all the following discharge criteria are met: >90% mass balance recovery; OR plasma/blood radioactivity levels below the limit of quantitation for 2 consecutive collections; and <1% of the total radioactive dose recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods. If these criteria are not met by Day 11, subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day 15 to continue 24-hour blood, urine and faeces collections for the analysis of total radioactivity, unless otherwise agreed upon by the Sponsor and Investigator. If the discharge criteria are not met by Day 15, subjects may be asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24-hour nonresidential collections will occur on Day 21 (±1 day) and Day 28 (±1 day). If on the second occasion the subject has still not met the desired criterion, then the subject will be discharged from the study, per Investigator and Sponsor decision. Pharmacokinetic samples and radioanalytical samples will be obtained through at least 240 hours postdose, and possibly up to 4 weeks postdose (radioanalytical samples only), in case of not meeting discharge criteria. Samples for metabolite profiling/identification will be obtained through 240 hours postdose.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-Benznidazole | Experimental | Drug: [14C]-BenznidazoleA single dose of 100 mg [14C]-BNZ, orally administered on Day 1 following an overnight fast. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males of any race, between 35 and 65 years of age, inclusive, at screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at screening or check-in as assessed by the Investigator (or designee).
- Will agree to use contraception as detailed in Section 7.6.
- History of a minimum of 1 bowel movement per day.
Key exclusion criteria (22 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of dermatological conditions within the 6 months prior to dosing, such as rash, pruritus, and dermatitis, as determined by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is acceptable.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
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 |
|---|---|---|
| [14C]-BenznidazoleAlso: BNZA single dose level of 100 mg; 200 μCi (7.4 MBq) | Drug | [14C]-Benznidazole |
Primary outcome
Cmax of BNZ in plasma
Time frame: Days 1-29
maximum observed concentration (Cmax) in plasma
Mass balance of [14C]-BNZ
Time frame: Days 1-29
Mass balance of [14C]-BNZ in urine and faeces
Chemical structure of [14C]-BNZ metabolites
Time frame: Days 1-29
Characterization of the chemical structure and identification of metabolites of [14C]-BNZ in plasma, urine, and faeces
tmax of BNZ in plasma
Time frame: Days 1-29
time to maximum concentration (tmax) in plasma
AUC0-t of BNZ in plasma
Time frame: Days 1-29
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in plasma
AUC0-∞ of BNZ in plasma
Time frame: Days 1-29
AUC from time zero to infinity (AUC0-∞) in plasma
% AUC extrap of BNZ in plasma
Time frame: Days 1-29
percentage extrapolation (% AUCextrap) in plasma
t1/2 of BNZ in plasma
Time frame: Days 1-29
apparent terminal elimination half-life (t1/2) in plasma
CL/Fof BNZ in plasma
Time frame: Days 1-29
apparent oral clearance (CL/F) in plasma
Vz/F of BNZ in plasma
Time frame: Days 1-29
volume of distribution during the elimination phase for BNZ (Vz/F) in plasma
Cmax of [14C]-BNZ in plasma
Time frame: Days 1-29
maximum observed concentration (Cmax) in plasma
tmax of [14C]-BNZ in plasma
Time frame: Days 1-29
time to maximum concentration (tmax) in plasma
AUC0-t of [14C]-BNZ in plasma
Time frame: Days 1-29
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in plasma
AUC0-∞ of [14C]-BNZ in plasma
Time frame: Days 1-29
AUC from time zero to infinity (AUC0-∞) in plasma
% AUC extrap of [14C]-BNZ in plasma
Time frame: Days 1-29
percentage extrapolation (% AUCextrap) in plasma
t1/2 of [14C]-BNZ in plasma
Time frame: Days 1-29
apparent terminal elimination half-life (t1/2) in plasma
Cmax of [14C]-BNZ in whole blood
Time frame: Days 1-29
maximum observed concentration (Cmax) in whole blood
tmax of [14C]-BNZ in whole blood
Time frame: Days 1-29
time to maximum concentration (tmax) in whole blood
AUC0-t of [14C]-BNZ in whole blood
Time frame: Days 1-29
area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) in whole blood
AUC0-∞ of [14C]-BNZ in whole blood
Time frame: Days 1-29
AUC from time zero to infinity (AUC0-∞) in whole blood
% AUCextrap of [14C]-BNZ in whole blood
Time frame: Days 1-29
percentage extrapolation (% AUCextrap) in whole blood
t1/2 of [14C]-BNZ in whole blood
Time frame: Days 1-29
apparent terminal elimination half-life (t1/2) in whole blood
Total radioactivity AUC ratio
Time frame: Days 1-29
Total radioactivity AUC ratio (blood/plasma)
17 secondary outcomes
The incidence and severity of Adverse Events (AEs)
Time frame: Days 1-29
The incidence of laboratory abnormalities (haematology)
Time frame: Days 1-29
The incidence of laboratory abnormalities (clinical chemistry)
Time frame: Days 1-29
The incidence of laboratory abnormalities (urinalysis)
Time frame: Days 1-29
Measurement of QT interval (QTcB)
Time frame: Days 1-29
Measurement of QT interval (QTcF)
Time frame: Days 1-29
Measurement of PR intervals
Time frame: Days 1-29
Measurement of QT intervals
Time frame: Days 1-29
Measurement of QRS duration
Time frame: Days 1-29
Measurement of RR
Time frame: Days 1-29
Measurement of heart rate
Time frame: Days 1-29
Measurement of blood pressure
Time frame: Days 1-29
Measurement of Physical Examination
Time frame: Days 1-29
Measurement of supine pulse rate
Time frame: Days 1-29
Measurement body temperature
Time frame: Days 1-29
Measurement of Weight
Time frame: Days 1-29
Measurement of Height
Time frame: Days 1-29
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 14 Nov 2018.
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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.
Sunu Valasseri, MBBS, MSc principal investigator
Covance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-Benznidazole in people with Healthy Male Subjects, run by Exeltis France at 1 site in United Kingdom.
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 6 inclusion and 22 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Cmax of BNZ in plasma (time frame: Days 1-29). The study lists 23 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 14 Nov 2018.