- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01819922
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
March 30, 2016 updated by: Pfizer
A Phase 1 Randomized, Double-blind, Placebo-controlled, Two-way Crossover Study To Assess The Effect Of Pf-05175157 As A Single Oral Dose On Metabolic And Cardiopulmonary Parameters During Steady State And Graded Exercise In Healthy Subjects
This study is designed to assess the effect of one single dose of PF-05175157 on metabolic and cardiopulmonary parameters before, during and after treadmill exercise in healthy volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects of non child bearing potential only, between the ages of 18 and 40 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).
- Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects with maximum effort studies (peak RER >1.05) and normal exercise capacity as defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days prior to initiation of the study.
Exclusion Criteria:
- 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).
- History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -3 (±1).
- Dry eye symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo powder in capsule, one dose within 5 minutes prior to AM meal
|
Experimental: PF-05175157
|
600 mg as powder in capsule, one dose within 5 minutes prior to AM meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose
Time Frame: 20 minutes pre-dose
|
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension.
Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
|
20 minutes pre-dose
|
Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose
Time Frame: 1 hour 30 minutes post-dose
|
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension.
Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
|
1 hour 30 minutes post-dose
|
Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose
Time Frame: 2 hours 5 minutes post-dose
|
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension.
Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
|
2 hours 5 minutes post-dose
|
Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose
Time Frame: 1 hour 40 minutes post-dose
|
OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort.
OUES relates oxygen uptake to total ventilation during exercise.
|
1 hour 40 minutes post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 5-10 days after last dose of study drug (up to 25 days)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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; or congenital anomaly; or a medically important event.
Treatment-emergent were events between first dose of study drug and up to 5-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Adverse events included both serious and non-serious adverse events.
|
Baseline up to 5-10 days after last dose of study drug (up to 25 days)
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Baseline up-to 3 hours post-dose
|
Criteria for clinically significant:Hematology (hemoglobin,hematocrit,red blood corpuscles [RBC] count:less than [<]0.8*lower
limit of normal [LLN];platelets:<0.5*LLN/greater
than [>]1.75*upper
limit of normal [ULN];white blood corpuscles [WBC]:<0.6*LLN
or >1.5*ULN;lymphocytes, total neutrophils:<0.8*LLN
or >1.2*ULN;basophils,eosinophil, monocytes:>1.2*ULN);Liver
Function(aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase:>0.3*ULN;total
protein,albumin:<0.8*LLN
or >1.2*ULN;total bilirubin:>1.5*ULN);Renal
Function (blood urea nitrogen,creatinine:>1.3*ULN; uric acid:>1.2*ULN);Electrolytes
(sodium:<0.95*LLN or >1.05*ULN,potassium,chloride, calcium,bicarbonate:<0.9*LLN or >1.1*ULN; glucose fasting:<0.6*LLN or >1.5*ULN);Urinalysis (urine pH:>1.5*ULN
or >4.5;urine glucose,ketones,proteins, nitrites, leukocyte esterase,blood/hemoglobin:greater than or equal to (>=)1;urine WBC and RBC,urine bacteria:>=20/High Power Field [HPF];epithelial cells:>=6/HPF).
|
Baseline up-to 3 hours post-dose
|
Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data
Time Frame: Baseline up-to 3 hours post-dose
|
Participants who met the pre-defined criteria for clinically significant cardiovascular events were reported.
Criteria for clinically significant cardiovascular events: Blood pressure (BP) [supine systolic and sitting systolic BP (SBP): <90 millimeter of mercury (mm Hg), >=30 mmHg maximum increase and decrease from baseline in same posture; supine diastolic and sitting diastolic BP (DBP): <50 mm Hg, >=20 mmHg maximum increase and >=30 mmHg maximum decrease from baseline in same posture]; pulse rate: supine and sitting: <40 or >120 bpm.
|
Baseline up-to 3 hours post-dose
|
Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters
Time Frame: Baseline up-to 3 hour post-dose
|
Criteria for clinically significant ECG values included: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent (%) from baseline value of >200 msec and >=50 % for baseline value of <=200 msec, maximum QRS interval >=140 msec or maximum increase of >=50% for baseline value of >100 msec; QT interval corrected using the Fridericia formula (QTcF) 450-<480 msec, 480-<500, >=500 msec or increase of >45 msec or maximum increase of >=30 to <60 and >=60 msec for QT interval where, PR interval: interval between the start of the P wave and the start of the QRS complex corresponding to the time between the onset of atrial depolarization and onset of ventricular depolarization; QRS interval: time from electrocardiogram Q wave to the end of the T wave corresponding to ventricle depolarization, QTcF interval: time corresponding to the beginning of depolarization to repolarization of the ventricles.
|
Baseline up-to 3 hour post-dose
|
Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)
Time Frame: 1 hour 40 minutes post-dose
|
VO2 was the maximum rate of oxygen consumption as measured during incremental or prolonged, sub-maximal exercise.
It reflects the aerobic physical fitness of the individual.
It was assessed during indirect measure of heat production (calorimetry).
The unit of measure is milliliter per kilogram per minute (mL/kg/min).
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)
Time Frame: 1 hour 40 minutes post-dose
|
RER was defined as the ratio between the amount of oxygen (O2) consumed and carbon dioxide (CO2) produced in one breath.
The parameter was assessed during indirect measure of heat production (calorimetry).
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)
Time Frame: 1 hour 40 minutes post-dose
|
VE/VCO2 slope was also termed as ventilator efficiency.
It was defined as the amount of minute ventilation required to eliminate 1 liter of carbon dioxide.
The determinants of VE/VCO2 included fractional dead space and partial pressure of carbon dioxide.
The parameter was assessed during indirect calorimetry.
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)
Time Frame: 1 hour 40 minutes post-dose
|
VO2 at anaerobic threshold was widely recognized as a sub-max indicator of fitness.
The parameter was assessed during indirect calorimetry.
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Oxygen (O2) Pulse
Time Frame: 1 hour 40 minutes post-dose
|
Oxygen Pulse (VO2 /Heart Rate) was equal to stroke volume multiplied by oxygen extraction.
This parameter was assessed during cardiopulmonary exercise test.
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics
Time Frame: 1 hour 40 minutes post-dose
|
Oxygen kinetics describes the dependence of respiration of isolated cells on oxygen partial pressure.
The characteristics of oxygen uptake kinetics differ with intensity of exercise.
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Aerobic Efficiency
Time Frame: 1 hour 40 minutes post-dose
|
Aerobic efficiency was defined as volume of oxygen divided by work.
This parameter was assessed during cardiovascular exercise test.
|
1 hour 40 minutes post-dose
|
Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)
Time Frame: 1 hour 40 minutes post-dose
|
Physical work capacity evaluates the capacity of an individual to perform physically demanding work tasks.
PWC 130 was a simple sub-max exercise parameter that can be used as surrogate for fitness that was independent of metabolic cart measurements.
Interventions that improve fitness improve the PWC 130.
|
1 hour 40 minutes post-dose
|
Cardiac Structure: Left Ventricular Volume
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat.
It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).
Left ventricular volume was reported using modified Simpson's technique.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in the Left Ventricular Volume
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat.
It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).
Change from baseline in left ventricular volume was reported using modified Simpson's technique.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Cardiac Structure: Left Ventricular Wall Thickness
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Left ventricle is the chamber in the heart responsible for pumping blood to the rest of the body.
Thickening of the lower chambers of left ventricular wall is also termed as ventricular hypertrophy.
It was assessed by echocardiography using 2-dimensional gray-scale imaging; M-mode.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Cardiac Structure: Left Ventricular Geometry
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Left ventricular geometry was assessed by echocardiography using 2-dimensional gray-scale imaging.
Relative wall thickness was the index of left ventricular geometry and defined as the sum of interventricular septal thickness (mm) and posterior wall thickness (mm) divided by LV internal end-diastolic diameter (mm).
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Cardiac Structure: Right Ventricular Dimension
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Right ventricle is the chamber in the heart responsible for pumping blood to the lungs.
Right ventricular dimensions included end-diastole area (EDA) and end-systole area (ESA).
It was assessed by echocardiography using 2-dimensional gray-scale imaging.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Right Ventricular Dimension
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Right ventricle is the chamber in the heart responsible for pumping blood to the lungs.
Right ventricular dimensions included end-diastole area and end-systole area.
It was assessed by echocardiography using 2-dimensional gray-scale imaging.
Change from baseline in right ventricular dimension was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Cardiac Structure: Atrial Volume
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method.
Both end-systole volumes (ESV) and end-diastole volumes (EDV) were reported.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Atrial Volumes
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method.
Both end-systole volumes and end-diastole volumes were reported.
Change from baseline in atrial volume was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic Function: Ejection Fraction
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography.
EDV was the volume of blood within a ventricle immediately before a contraction.
Ejection fraction served as a general measure of the cardiac function of a participant.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Ejection Fraction
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic ejection fraction was the fraction of the end-diastolic volume that was ejected out of left ventricle with each contraction, estimated by echocardiography.
EDV was the volume of blood within a ventricle immediately before a contraction.
Ejection fraction served as a general measure of the cardiac function of a participant.
Change from baseline in ejection fraction was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic Function: Peak Contractile Velocity
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Peak Contractile Velocity
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).
Change from baseline in peak contractile velocity was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic Function: Rotation/Torsion
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Torsion is the twisting of an object due to an applied torque.
It is expressed in newton metres.
The left ventricle twists in systole storing potential energy and untwists (recoils) in diastole releasing the energy.
Twist aids left ventricular ejection and untwist aids relaxation and ventricular filling.
Therefore, rotation and torsion are important in cardiac mechanics.
It was assessed by echocardiography using speckled tracking analysis .
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Systolic Function: Global Strain Rate
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes
|
Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension.
Global strain rate was assessed by echocardiography using speckled tracking analysis.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes
|
Change From Baseline in Systolic Global Strain Rate
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension.
Global strain rate was assessed by echocardiography using speckled tracking analysis.
Change from baseline in systolic global strain rate was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Trans-mitral Doppler: Ratio
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes
|
Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity.
The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart.
It was determined on spectral doppler echocardiography.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes
|
Change From Baseline in Trans-mitral Doppler Ratio
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity.
The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart.
It was determined on spectral doppler echocardiography.
Change from baseline in trans-mitral ration was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Trans-mitral Doppler: Time
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve.
It was determined on spectral doppler echocardiography.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Trans-mitral Doppler Time
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve.
It was determined on spectral doppler echocardiography.
Change from baseline in trans-mitral doppler time was reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Early and Late Peak Tissue Velocity
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Tissue velocities were measured off-line from two dimensional (2D) color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles.
Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound.
Early and late peak tissue velocities (EPV and LPV) were reported.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Change From Baseline in Early and Late Peak Velocity
Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Tissue velocities were measured off-line from 2D color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles.
Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound.
Change from baseline in early and late peak tissue velocities were reported.
|
1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Diastolic Strain Rate
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Diastolic strain rate was defined as the rate of percent change in all segments of left ventricular dimension in comparison to its original dimension.
It was assessed by echocardiography using speckled tracking analysis.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Peak Diastolic Untwisting Rate
Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Diastolic untwisting is an important component of early diastolic left ventricular filling.
Left ventricular diastolic function is determined by early diastolic relaxation and myocardial stiffness.
Peak diastolic untwisting rate is defined as the rate of left ventricular relaxation.
It was assessed by echocardiography using speckled tracking analysis.
|
20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose
|
Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise
Time Frame: 1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose
|
Plasma metabolomic profiles before and immediately following steady state and incremental exercise were collected using vacutainer tube containing dipotassium ethylenediamine tetraacetic Acid (K2EDTA) were processed by the clinical site according to handling specifications.
|
1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
February 24, 2013
First Submitted That Met QC Criteria
March 25, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Estimate)
May 2, 2016
Last Update Submitted That Met QC Criteria
March 30, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- B1731008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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