Normal HealthyPhase 1NCT02778477
Topical Multiple Ascending Dose Study for PF-06423264
A Phase 1 study testing PF-06423264 in people with Normal Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy
- What is being tested?
- PF-06423264
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 23 May 2016to 23 May 2017
- 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 males and female of non-childbearing potential;
- Body Mass Index 17.5-35.5 kg/m2;
- Body weight >50 kg;
Who cannot join
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-06423264 Administered Topically To Sequential Cohorts Of Healthy Subjects With And Without Oily Skin
The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.
- Conditions
- Normal Healthy
- Being tested
- PF-06423264, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06423264Drug
Multiple ascending dose of PF-06423264
PlaceboOther
Also called Placebo comparator
Multiple dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A_Cohort 1_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 1_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 2_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 2_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 3_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 3_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 4_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 4_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 5_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 5_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 6_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 6_Placebo | Placebo comparator | Multiple dose of placebo Receives: Other: Placebo |
| Part A_Cohort 7_Active | Experimental | Multiple ascending dose of PF-06423264 Receives: Drug: PF-06423264 |
| Part A_Cohort 7_Placebo | Placebo comparator | Multiple ascending dose of placebo Receives: Other: Placebo |
| Part B_Cohort 1_Active | Experimental | Multiple doses of PF-06423264 Receives: Drug: PF-06423264 |
| Part B_Cohort 1_Placebo | Placebo comparator | Multiple doses of placebo Receives: Other: Placebo |
| Part B_Cohort 2_Active | Experimental | Multiple doses of PF-06423264 Receives: Drug: PF-06423264 |
| Part B_Cohort 2_Placebo | Placebo comparator | Multiple doses of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline (Day 0) up to 28 days after last dose of study medication
Number of Participants with Draize-like scoring and clinical observation
Modified Draize-like scoring and clinical observation. Severity estimated by clinical signs and scoring; ranged 0-4: 0= No reaction visible, 1= Trace reaction - barely perceptible pinkness, 2= Mild reaction - readily visible pinkness, 3= Moderate reaction - definite redness, 4= Strong to severe reaction - very intense redness.
Measured: Baseline (Day 1) up to Day 42+3
Number of Participants With Clinical Laboratory Abnormalities
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
Measured: Baseline (Day 0) up to 28 days after last dose
Number of Participants With Abnormal Electrocardiogram (ECG)
Criteria for potential clinical concern in ECG parameters: Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Measured: Baseline (Day 0) up to 28 days after last dose
Number of Participants With Categorical Vital Signs Data
Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg was reported.
Measured: Baseline (Day 0) up to 28 days after last dose
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax) for PF-06423264
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Time to Reach Maximum Observed Concentration for PF-06423264
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06423264
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Measured: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Plasma Decay Half-Life (t1/2) for PF-06423264
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Apparent Volume of Distribution (Vz/F) for PF-06423264
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, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Apparent Total Body Clearance (CL/F) for
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 apparent total body 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, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Observed Accumulation Ratio (Rac) for PF-06423264
Rac was calculated as, area under the curve from time zero to end of dosing interval on Day Y (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day X(AUCtau).
Measured: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
change from baseline in sebum lipid components and sebum excretion
change from baseline in sebum lipid components and sebum excretion as assessed with Sebutape strips and Sebumeter measurements on the forehead of subjects with oily skin
Measured: Baseline (Day 0) up to 16 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start23 May 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Why it stopped: Preliminary analysis of accrued data failed to indicate any meaningful pharmacodynamic response.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 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
- NCT02778477
- Sponsor's protocol ID
- B7561002
- Other IDs
- 2014-003736-39, 2014
- Status last verified
- Jun 2017
- First submitted
- 17 May 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-06423264 Administered Topically To Sequential Cohorts Of Healthy Subjects With And Without Oily Skin
- ClinicalTrials.gov ID
- NCT02778477
- Acronym / sponsor ID
- B7561002
- Conditions
- Normal Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis of accrued data failed to indicate any meaningful pharmacodynamic response.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 20 May 2016 (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.
The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part A_Cohort 1_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 1_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 2_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 2_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 3_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 3_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 4_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 4_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 5_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 5_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 6_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 6_Placebo | Placebo comparator | Other: PlaceboMultiple dose of placebo |
| Part A_Cohort 7_Active | Experimental | Drug: PF-06423264Multiple ascending dose of PF-06423264 |
| Part A_Cohort 7_Placebo | Placebo comparator | Other: PlaceboMultiple ascending dose of placebo |
| Part B_Cohort 1_Active | Experimental | Drug: PF-06423264Multiple doses of PF-06423264 |
| Part B_Cohort 1_Placebo | Placebo comparator | Other: PlaceboMultiple doses of placebo |
| Part B_Cohort 2_Active | Experimental | Drug: PF-06423264Multiple doses of PF-06423264 |
| Part B_Cohort 2_Placebo | Placebo comparator | Other: PlaceboMultiple doses of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and female of non-childbearing potential;
- Body Mass Index 17.5-35.5 kg/m2;
- Body weight >50 kg;
Key exclusion criteria (1 listed)
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
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-06423264Multiple ascending dose of PF-06423264 | Drug | Part A_Cohort 1_Active, Part A_Cohort 2_Active, Part A_Cohort 3_Active, Part A_Cohort 4_Active, Part A_Cohort 5_Active, Part A_Cohort 6_Active, Part A_Cohort 7_Active, Part B_Cohort 1_Active, Part B_Cohort 2_Active |
| PlaceboAlso: Placebo comparatorMultiple dose of placebo | Other | Part A_Cohort 1_Placebo, Part A_Cohort 2_Placebo, Part A_Cohort 3_Placebo, Part A_Cohort 4_Placebo, Part A_Cohort 5_Placebo, Part A_Cohort 6_Placebo, Part A_Cohort 7_Placebo, Part B_Cohort 1_Placebo, Part B_Cohort 2_Placebo |
Primary outcome
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Time frame: Baseline (Day 0) up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Number of Participants with Draize-like scoring and clinical observation
Time frame: Baseline (Day 1) up to Day 42+3
Modified Draize-like scoring and clinical observation. Severity estimated by clinical signs and scoring; ranged 0-4: 0= No reaction visible, 1= Trace reaction - barely perceptible pinkness, 2= Mild reaction - readily visible pinkness, 3= Moderate reaction - definite redness, 4= Strong to severe reaction - very intense redness.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline (Day 0) up to 28 days after last dose
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: Baseline (Day 0) up to 28 days after last dose
Criteria for potential clinical concern in ECG parameters: Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Number of Participants With Categorical Vital Signs Data
Time frame: Baseline (Day 0) up to 28 days after last dose
Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg was reported.
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Time to Reach Maximum Observed Concentration for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Plasma Decay Half-Life (t1/2) for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Apparent Volume of Distribution (Vz/F) for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Apparent Total Body Clearance (CL/F) for
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
Observed Accumulation Ratio (Rac) for PF-06423264
Time frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14
change from baseline in sebum lipid components and sebum excretion
Time frame: Baseline (Day 0) up to 16 days after last dose of study medication
Results and safety
The study was stopped early (reason given: Preliminary analysis of accrued data failed to indicate any meaningful pharmacodynamic response.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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-06423264 in people with Normal Healthy, run by Pfizer at 1 site in Belgium.
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 3 inclusion and 1 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 21 Jun 2017. 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 Belgium. 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. 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 (reason given: Preliminary analysis of accrued data failed to indicate any meaningful pharmacodynamic response.). 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?
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns (time frame: Baseline (Day 0) up to 28 days after last dose of study medication). 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 21 Jun 2017.