CClinicalTrials.gg
CompletedNCT04594252Updated Aug 19, 2024Results posted

Copper Balance in Healthy Participants Administered ALXN1840

A Phase 1 interventional study of ALXN1840 in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.

Read the detailed description

This study will also characterize the steady state absorption, distribution, metabolism, and excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840 disposition.

Safety will be monitored throughout the study.

02

Conditions studied

  • Healthy

Keywords

  • Copper Balance
  • Molybdenum Balance
  • Healthy
  • ALXN1840
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Have regular bowel movements (at least once per day).
  2. Adequate venous access in the left or right arm to allow collection of study-required blood samples.
  3. Willing and able to adhere to all dietary requirements of the study.
  4. Body weight between 50 to 70 kilograms (kg) (inclusive) for female participants, and 65 to 85 kg (inclusive) for male participants, and body mass index within the range 18 to 25 kg/meters squared (inclusive).
  5. Willing and able to follow protocol-specified contraception requirements.
  6. Capable of giving signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Significant medical history (current or past).
  2. History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
  3. Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or > 140/90 mmHg.
  4. Lymphoma, leukemia, or any malignancy within 3 years.
  5. Breast cancer within the past 10 years.
  6. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal at Screening.
  7. Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening.
  8. History of anemia or hemoglobin \< 130 gram (g)/Liter (L) for men and hemoglobin \< 115 g/L for women at Screening.
  9. History of benign ethnic neutropenia or absolute neutrophil count \< 1500/microliter (uL), lymphocyte count below 1000/uL.
  10. QTcF> 450 millisecond (ms) for men and QTcF> 480 ms for women.
  11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    ALXN1840

    Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days.

    Drug: ALXN1840

Interventions

  • DrugALXN1840

    Administered orally as tablets.

    Also known as: formerly WTX101

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)

    Copper balance was defined as the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

    Time frame: Baseline, Days 4 to 15

Secondary outcomes

  1. Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing

    Copper balance was defined by the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period.

    Time frame: Day 4 through Day 15

  2. Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

    Time frame: Baseline, Days 12 to 15

  3. Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1. Molybdenum excretion for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

    Time frame: Baseline, Days 4 to 15

  4. Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period.

    Time frame: Day 1 through Day 15

  5. Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing

    Copper balance for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

    Time frame: Days 4 to 15

  6. Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30

    Copper balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

    Time frame: Day 1 through Day 30

  7. Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration

    Time frame: Day 15 (predose and 24 hours postdose)

  8. Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine

    Molybdenum balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

    Time frame: Day 1 through Day 30

  9. Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

  10. Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

  11. Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

07

Results

Posted Aug 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: ALXN1840Group 2: ALXN1840
Started611
Received at least 1 dose of study drug611
Completed69
Not completed02
Withdrew: Adverse event02

Outcome measures

PrimaryChange From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)

Copper balance was defined as the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

Time frame:
Baseline, Days 4 to 15
Reported as:
Mean · mg/day
Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)
mg/dayGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)-0.0749 ± 0.374190.6901 ± 0.481760.4201 ± 0.57518
SecondaryMean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing

Copper balance was defined by the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period.

Time frame:
Day 4 through Day 15
Reported as:
Mean · mg/day
Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing
mg/dayGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing0.7789 ± 0.202971.0218 ± 0.212790.9361 ± 0.23558
SecondaryChange From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)

Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

Time frame:
Baseline, Days 12 to 15
Reported as:
Mean · mg/day
Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)
mg/dayGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)1.7750 ± 0.981610.6189 ± 1.243371.0269 ± 1.26161
SecondaryChange From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)

Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1. Molybdenum excretion for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

Time frame:
Baseline, Days 4 to 15
Reported as:
Mean · mg
Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)
mgGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Urine2.6210 ± 0.686812.5957 ± 0.396882.6046 ± 0.49600
Feces2.0247 ± 0.641991.9586 ± 0.328541.9819 ± 0.44421
SecondaryMean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)

Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period.

Time frame:
Day 1 through Day 15
Reported as:
Mean · mg/day
Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)
mg/dayGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)2.5560 ± 0.730422.2861 ± 0.356542.3813 ± 0.51367
SecondaryCopper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing

Copper balance for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

Time frame:
Days 4 to 15
Reported as:
Mean · mg
Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing
mgGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Copper Quantified in Food1.5039 ± 0.100251.7178 ± 0.122471.6423 ± 0.15366
Copper Quantified in Drink0.0270 ± 0.001200.0108 ± 0.001940.0165 ± 0.00816
Copper Quantified in Feces0.7373 ± 0.239860.6895 ± 0.171020.7064 ± 0.19187
Copper Quantified in Urine0.0147 ± 0.011020.0173 ± 0.007800.0164 ± 0.00881
SecondaryCopper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30

Copper balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

Time frame:
Day 1 through Day 30
Reported as:
Mean · mg
Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30
mgGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Copper Quantified in Food1.6117 ± 0.127361.6673 ± 0.127791.6476 ± 0.12659
Copper Quantified in Drink0.0252 ± 0.001240.0124 ± 0.002120.0169 ± 0.00658
Copper Quantified in Feces0.7017 ± 0.190090.6962 ± 0.133850.6982 ± 0.14999
Copper Quantified in Urine0.0192 ± 0.011070.0209 ± 0.006550.0203 ± 0.00811
SecondaryPlasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration
Time frame:
Day 15 (predose and 24 hours postdose)
Reported as:
Mean · micromoles (μmol)/liter (L)
Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration
micromoles (μmol)/liter (L)Group 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Total Copper Concentration at Day 15 (predose)12.58931 ± 1.63664013.87256 ± 1.62749613.41964 ± 1.700617
Total Copper Concentration at Day 15 (24 hours postdose)12.56570 ± 1.34250214.49816 ± 1.54844113.77349 ± 1.724230
LBC Concentration at Day 15 (predose)0.93213 ± 0.2626550.82360 ± 0.1608870.86190 ± 0.201482
LBC Concentration at Day 15 (24 hours postdose)1.04386 ± 0.2335260.90612 ± 0.2647910.95777 ± 0.254932
SecondaryMolybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine

Molybdenum balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

Time frame:
Day 1 through Day 30
Reported as:
Mean · mg
Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine
mgGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Molybdenum Quantified in Food0.2618 ± 0.022750.1414 ± 0.011230.1839 ± 0.06129
Molybdenum Quantified in Drink0.0014 ± 0.000150.0017 ± 0.000480.0016 ± 0.00041
Molybdenum Quantified in Feces1.0575 ± 0.293590.9949 ± 0.160821.0170 ± 0.20988
Molybdenum Quantified in Urine1.4016 ± 0.354151.3848 ± 0.218741.3907 ± 0.26300
Molybdenum Quantified in ALXN1840 Doses Given3.5933 ± 0.022773.3625 ± 0.281013.4439 ± 0.24988
SecondaryMaximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum
Time frame:
Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Reported as:
Mean · nanograms (ng)/mL
Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum
nanograms (ng)/mLGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Cmax of Total Molybdenum at Day 1303.000 ± 65.3667291.727 ± 100.7324295.706 ± 87.7950
Cmax of Total Molybdenum at Day 15358.500 ± 53.6945382.333 ± 78.2624372.800 ± 68.3794
Cmax of PUF Molybdenum at Day 130.445 ± 12.061327.266 ± 12.939628.388 ± 12.3515
Cmax of PUF Molybdenum at Day 1593.717 ± 42.936874.678 ± 36.161782.293 ± 38.7152
SecondaryArea Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum
Time frame:
Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Reported as:
Mean · hours*ng/mL
Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum
hours*ng/mLGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
AUCtau of Total Molybdenum at Day 14860.289 ± 1078.2634439.012 ± 1374.8694587.698 ± 1260.082
AUCtau of Total Molybdenum at Day 156770.905 ± 582.7707496.724 ± 1499.3707206.397 ± 1241.529
AUCtau of PUF Molybdenum at Day 1356.156 ± 133.8174318.123 ± 131.9084331.546 ± 129.6990
AUCtau of PUF Molybdenum at Day 151035.231 ± 252.0931913.807 ± 379.1750962.376 ± 329.6126
SecondaryObserved Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum
Time frame:
Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Reported as:
Mean · ng/mL
Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum
ng/mLGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
Ctau of Total Molybdenum at Day 1143.800 ± 35.5348140.436 ± 53.2088141.624 ± 46.5492
Ctau of Total Molybdenum at Day 15218.833 ± 23.0340242.625 ± 54.5892232.429 ± 44.2488
Ctau of PUF Molybdenum at Day 14.655 ± 1.16234.785 ± 1.66024.739 ± 1.4660
Ctau of PUF Molybdenum at Day 1511.060 ± 1.378511.141 ± 2.849211.106 ± 2.2591

Adverse events

Collected over Baseline up to Day 43. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: ALXN18400/6 (0%)0/6 (0%)5/6 (83.3%)
Group 2: ALXN18400/11 (0%)0/11 (0%)9/11 (81.8%)
Total (Groups 1 and 2): ALXN18400/17 (0%)0/17 (0%)14/17 (82.4%)
Most frequent other events
Showing 10 of 23
Most frequent other events
EventGroup 1: ALXN1840Group 2: ALXN1840Total (Groups 1 and 2): ALXN1840
DysmenorrhoeaReproductive system and breast disorders2/30/62/9
NauseaGastrointestinal disorders1/64/115/17
Liver function test abnormalInvestigations0/62/112/17
HeadacheNervous system disorders1/62/113/17
Abdominal painGastrointestinal disorders1/60/111/17
FolliculitisInfections and infestations1/60/111/17
Viral upper respiratory tract infectionInfections and infestations1/60/111/17
Weight decreasedInvestigations1/60/111/17
DizzinessNervous system disorders1/60/111/17
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/60/111/17

Baseline characteristics

Full analysis set included all participants who received at least 1 dose of ALXN1840.

Age, Continuous
Age, Continuous(years)Group 1: ALXN1840Group 2: ALXN1840Total
Mean27.0 ± 6.2929.5 ± 5.6128.6 ± 5.80
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: ALXN1840Group 2: ALXN1840Total
Female369
Male358
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: ALXN1840Group 2: ALXN1840Total
Hispanic or Latino011
Not Hispanic or Latino61016
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: ALXN1840Group 2: ALXN1840Total
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American022
White5813
More than one race000
Unknown or Not Reported000
Mean Daily Copper Balance
Mean Daily Copper Balance(milligrams (mg)/day)Group 1: ALXN1840Group 2: ALXN1840Total
Mean0.8538 ± 0.486290.3317 ± 0.445680.5160 ± 0.51399
Mean Daily Molybdenum Balance
Mean Daily Molybdenum Balance(mg/day)Group 1: ALXN1840Group 2: ALXN1840Total
Mean0.1286 ± 0.044690.0133 ± 0.050350.0540 ± 0.07372
Total Molybdenum Excretion in Feces
Total Molybdenum Excretion in Feces(mg)Group 1: ALXN1840Group 2: ALXN1840Total
Mean0.0586 ± 0.023470.0724 ± 0.030230.0675 ± 0.02809
Total Molybdenum Excretion in Urine
Total Molybdenum Excretion in Urine(mg)Group 1: ALXN1840Group 2: ALXN1840Total
Mean0.1039 ± 0.026560.1198 ± 0.035460.1142 ± 0.03268
08

Study locations

1 site
  • Clinical Study Site
    London, United Kingdom
09

References and documents

Study documents

  • Study protocol · May 29, 2020
  • Statistical analysis plan · Jul 20, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04594252
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 20, 2020
Start date
Jul 1, 2020
Primary completion
Nov 18, 2020
Completion
Nov 18, 2020
Results posted
Aug 19, 2024
Last update
Aug 19, 2024

Study contacts

Eugene S. Swenson, MD, PhD
study director · Alexion Pharmaceuticals, Inc.
Peter Ksenuk, MD
study director · Alexion Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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