Healthy VolunteersPhase 1NCT02319148

A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

A Phase 1 study testing itraconazole, diltiazem and SR verapamil in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: itraconazole, diltiazem and SR verapamil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteBelgium
Study dates: Jul 2014to Oct 2014
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and/or female subjects 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) with a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a personally signed and dated informed consent document and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Participating female subjects of non-childbearing potential must meet at least one of the following criteria: achieved postmenopausal status; 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.

Who cannot join

Subjects cannot be included in the study if there is: the presence/ history of any disorder that prevents study completion
Evidence/history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Any surgical or medical condition that may interfere with the absorption distribution, metabolism, or excretion of the study drug
A positive urine drug screen or history of regular excessive alcohol consumption or use of tobacco-or nicotine-containing products in excess or from 24-hours prior to admission until discharge
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 halflives preceding the first dose of study med.
Out of range blood pressure including current evidence of orthostatic change in blood pressure
Abnormal ECG or history or current evidence of clinically important cardiac conduction abnormalities.
Also excluded are: pregnant or breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as described in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Open-label, 3-sequence, 4-treatment, Incomplete Block Design To Estimate The Effect Of Steady State Cyp3a4 Inhibitors (Itraconazole, Diltiazem Or Verapamil) On The Pharmacokinetics Of Singe Dose Pf-00489791 In Healthy Volunteers

The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

Conditions: Healthy Volunteers
Being tested: itraconazole, diltiazem, SR verapamil, PF-00489791

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

itraconazoleDrug
itraconazole dosed at 200 mg
diltiazemDrug
diltiazem dosed at 240 mg
SR verapamilDrug
SR verapamil dosed at 240 mg
PF-00489791Drug
PF-00489791 20 mg single dose administration

Study groups in NCT02319148
Study group	Role	What they receive
Treatment B	Experimental	Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily). Receives: Drug: itraconazole; Drug: PF-00489791
Treatment C	Experimental	Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily). Receives: Drug: diltiazem; Drug: PF-00489791
Treatment D	Experimental	Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily). Receives: Drug: SR verapamil; Drug: PF-00489791

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of PF-00489791
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration

Secondary outcomes (10)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Apparent Volume of Distribution (Vz/F) of PF-00489791
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: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Apparent Oral Clearance (CL/F) of PF-00489791
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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Terminal Elimination Half-Life (t1/2) of PF-00489791
t1/2 is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).
Measured: Baseline up to 28 days after last study drug administration
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.
Measured: Baseline up to Day 9
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Measured: Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2
Number of Participants Who Used at Least 1 Concomitant Medication
Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.
Measured: Baseline up to Day 15 (final study evaluation)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An 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 pre-treatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to 28 days after last study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2014

First posted18 Dec 2014 (estimated)
Study startJul 2014
Primary completionOct 2014
Study completionOct 2014

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 Healthy VolunteersStudies 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: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02319148
Sponsor's protocol ID: A7331022
Other IDs: 2014-001979-31, 2014
Status last verified: Jul 2016
First submitted: 17 Sep 2014
Last updated: 16 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: A Phase 1, Randomized, Open-label, 3-sequence, 4-treatment, Incomplete Block Design To Estimate The Effect Of Steady State Cyp3a4 Inhibitors (Itraconazole, Diltiazem Or Verapamil) On The Pharmacokinetics Of Singe Dose Pf-00489791 In Healthy Volunteers
ClinicalTrials.gov ID: NCT02319148
Acronym / sponsor ID: A7331022
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 18 Dec 2014 (estimated)
Results: Posted 16 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment B	Experimental	Drug: itraconazole, Drug: PF-00489791Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily).
Treatment C	Experimental	Drug: diltiazem, Drug: PF-00489791Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily).
Treatment D	Experimental	Drug: SR verapamil, Drug: PF-00489791Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male and/or female subjects 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) with a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a personally signed and dated informed consent document and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Participating female subjects of non-childbearing potential must meet at least one of the following criteria: achieved postmenopausal status; 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 (8 listed)

Subjects cannot be included in the study if there is: the presence/ history of any disorder that prevents study completion
Evidence/history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Any surgical or medical condition that may interfere with the absorption distribution, metabolism, or excretion of the study drug
A positive urine drug screen or history of regular excessive alcohol consumption or use of tobacco-or nicotine-containing products in excess or from 24-hours prior to admission until discharge
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 halflives preceding the first dose of study med.

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
itraconazoleitraconazole dosed at 200 mg	Drug	Treatment B
diltiazemdiltiazem dosed at 240 mg	Drug	Treatment C
SR verapamilSR verapamil dosed at 240 mg	Drug	Treatment D
PF-00489791PF-00489791 20 mg single dose administration	Drug	Treatment B, Treatment C, Treatment D

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.

10 secondary outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Apparent Volume of Distribution (Vz/F) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Apparent Oral Clearance (CL/F) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Terminal Elimination Half-Life (t1/2) of PF-00489791
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
Time frame: Baseline up to 28 days after last study drug administration
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Time frame: Baseline up to Day 9
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2
Number of Participants Who Used at Least 1 Concomitant Medication
Time frame: Baseline up to Day 15 (final study evaluation)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last study drug administration

Results and safety

Results posted to the registry on 16 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-00489791 20 mg	22	22
PF-00489791 20 mg + Itraconazole 200 mg	0	0
PF-00489791 20 mg + Diltiazem 240 mg	0	0
PF-00489791 20 mg + Verapamil 240 mg	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-00489791

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	PF-00489791 20 mg n = 22	PF-00489791 20 mg + Itraconazole 200 mg n = 6	PF-00489791 20 mg + Diltiazem 240 mg n = 6	PF-00489791 20 mg + Verapamil 240 mg n = 6
Value	1140 (34)	1238 (33)	1198 (33)	1186 (21)

PF-00489791 20 mg vs PF-00489791 20 mg + Itraconazole 200 mg: Ratio of adjusted geometric means: 105.28 (90% CI 92.11 to 120.34), Mixed Models Analysis
PF-00489791 20 mg vs PF-00489791 20 mg + Diltiazem 240 mg: Ratio of adjusted geometric means: 92.54 (90% CI 80.96 to 105.77), Mixed Models Analysis
PF-00489791 20 mg vs PF-00489791 20 mg + Verapamil 240 mg: Ratio of adjusted geometric means: 116.36 (90% CI 101.86 to 132.92), Mixed Models Analysis

Population analysed: The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	PF-00489791 20 mg n = 22	PF-00489791 20 mg + Itraconazole 200 mg n = 6	PF-00489791 20 mg + Diltiazem 240 mg n = 6	PF-00489791 20 mg + Verapamil 240 mg n = 6
Value	17880 (36)	18140 (24)	16840 (20)	19560 (30)

PF-00489791 20 mg vs PF-00489791 20 mg + Itraconazole 200 mg: Ratio of adjusted geometric means: 90.16 (90% CI 78.57 to 103.46), Mixed Models Analysis
PF-00489791 20 mg vs PF-00489791 20 mg + Diltiazem 240 mg: Ratio of adjusted geometric means: 106.38 (90% CI 92.70 to 122.07), Mixed Models Analysis
PF-00489791 20 mg vs PF-00489791 20 mg + Verapamil 240 mg: Ratio of adjusted geometric means: 101.71 (90% CI 88.68 to 116.66), Mixed Models Analysis

Population analysed: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 28 days after last study drug administration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-00489791 20 mg	0 of 22 (0%)	18 of 22 (81.8%)	Not reported
Itraconazole 200 mg	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
Diltiazem 240 mg	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Verapamil 240 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
PF-00489791 20 mg + Itraconazole 200 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
PF-00489791 20 mg + Diltiazem 240 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
PF-00489791 20 mg + Verapamil 240 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

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.
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 itraconazole, diltiazem and SR verapamil in people with Healthy Volunteers, 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 2 inclusion and 8 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 16 Sep 2016. 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. 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 16 Sep 2016). 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?

Maximum Observed Plasma Concentration (Cmax) of PF-00489791 (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02319148.

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.