HealthyPhase 1NCT02184429
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
A Phase 1 study testing PF-06669571 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06669571
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
- For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
- Conditions
- Healthy
- Being tested
- PF-06669571
- Keywords
- First in human, single ascending dose study, multiple ascending dose study, safety and tolerability, pharmacokinetics, food effect, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06669571Drug
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
PF-06669571Drug
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
PF-06669571Drug
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
PF-06669571Drug
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
PF-06669571Drug
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
PF-06669571Drug
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
PF-06669571Drug
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose-1 | Experimental | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design Receives: Drug: PF-06669571 |
| Single Ascending Dose-2 | Experimental | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design Receives: Drug: PF-06669571 |
| Multiple Ascending Dose-1 | Experimental | Daily dose of PF-06669571 in healthy volunteers Receives: Drug: PF-06669571 |
| Multiple Ascending Dose-2 | Experimental | Daily dose of PF-06669571 in healthy volunteers Receives: Drug: PF-06669571 |
| Multiple Ascending Dose-3 | Experimental | Daily dose of PF-06669571 in healthy volunteers Receives: Drug: PF-06669571 |
| Multiple Ascending Dose-4 | Experimental | Daily dose of PF-06669571 in healthy volunteers Receives: Drug: PF-06669571 |
| Multiple Ascending Dose-5 | Experimental | Daily dose of PF-06669571 in healthy volunteers Receives: Drug: PF-06669571 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: screening,Day 28
Secondary outcomes (21)
Maximum Observed Plasma Concentration (Cmax) after single dose
Cmax after a single dose
Measured: 0-Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
Measured: 0-Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
Measured: 0-Day 5
Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose
Tmax after single dose
Measured: 0-Day 5
Plasma Decay Half-Life (t1/2) after single dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
Measured: 0-Day 5
Apparent Oral Clearance (CL/F) after single dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose
Measured: 0-Day 5
Apparent Volume of Distribution (Vz/F) after single dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0-Day 5
Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose
Measured: 0-Day 18
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses
Measured: 0-Day 18
Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses
Measured: 0-Day 18
Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0-Day 18
Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses
Measured: 0-Day 18
Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses
Measured: 0-Day 18
Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses
Measured: 0-day 18
Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses
Measured: 0-Day 18
Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0-Day 18
Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0-Day 18
Renal clearance (CLr) on day 14
Measured: 0-Day 18
Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses
Measured: 0-Day 18
Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses
Measured: 0-Day 18
Peak to Trough ratio at Steady State (PTR)
Cmax to Cmin ratio at steady state
Measured: 0-Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
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 PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184429
- Sponsor's protocol ID
- B7821001
- Status last verified
- Mar 2016
- First submitted
- 3 Jul 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02184429
- Acronym / sponsor ID
- B7821001
- Conditions
- Healthy
- Keywords
- First in human, single ascending dose study, multiple ascending dose study, safety and tolerability, pharmacokinetics, food effect, Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jul 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.
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose-1 | Experimental | Drug: PF-06669571Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
| Single Ascending Dose-2 | Experimental | Drug: PF-06669571Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
| Multiple Ascending Dose-1 | Experimental | Drug: PF-06669571Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-2 | Experimental | Drug: PF-06669571Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-3 | Experimental | Drug: PF-06669571Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-4 | Experimental | Drug: PF-06669571Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-5 | Experimental | Drug: PF-06669571Daily dose of PF-06669571 in healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
- For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
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 |
|---|---|---|
| PF-06669571Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo | Drug | Single Ascending Dose-1 |
| PF-06669571Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo | Drug | Single Ascending Dose-2 |
| PF-06669571Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days | Drug | Multiple Ascending Dose-1 |
| PF-06669571Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days | Drug | Multiple Ascending Dose-2 |
| PF-06669571Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme | Drug | Multiple Ascending Dose-3 |
| PF-06669571Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme | Drug | Multiple Ascending Dose-4 |
| PF-06669571Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme | Drug | Multiple Ascending Dose-5 |
Primary outcome
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: screening,Day 28
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
21 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) after single dose
Time frame: 0-Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose
Time frame: 0-Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose
Time frame: 0-Day 5
Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose
Time frame: 0-Day 5
Plasma Decay Half-Life (t1/2) after single dose
Time frame: 0-Day 5
Apparent Oral Clearance (CL/F) after single dose
Time frame: 0-Day 5
Apparent Volume of Distribution (Vz/F) after single dose
Time frame: 0-Day 5
Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose
Time frame: 0-Day 18
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses
Time frame: 0-Day 18
Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses
Time frame: 0-Day 18
Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses
Time frame: 0-Day 18
Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses
Time frame: 0-Day 18
Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses
Time frame: 0-Day 18
Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses
Time frame: 0-day 18
Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses
Time frame: 0-Day 18
Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses
Time frame: 0-Day 18
Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses
Time frame: 0-Day 18
Renal clearance (CLr) on day 14
Time frame: 0-Day 18
Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses
Time frame: 0-Day 18
Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses
Time frame: 0-Day 18
Peak to Trough ratio at Steady State (PTR)
Time frame: 0-Day 18
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 6 Sep 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-06669571 in people with Healthy, run by Pfizer at 1 site in United States.
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 8 inclusion and 4 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 6 Sep 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 States. 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?
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: screening,Day 28). 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 6 Sep 2018.