Multi-drug Resistant TuberculosisPhase 1NCT04309656

Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid

A Phase 1 study testing Pretomanid in people with Multi-drug Resistant Tuberculosis, run by Global Alliance for TB Drug Development at 1 site in United States.

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

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Read more about this study

Who is it for?: Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Multi-drug Resistant Tuberculosis
What is being tested?: Pretomanid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2020to 28 Feb 2020
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 19 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female. Females must not be pregnant or breastfeeding.
Willing and able to comply with the contraception requirements.
Between 19 and 50 years of age (inclusive) at the time of screening.
Body mass index (BMI) between 18.50 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.

Who cannot join

History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
Vital signs at screening (measured sitting after a minimum 3 minutes rest) as follows: blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg or a heart rate lower than 40 bpm or higher than 99 bpm. Out-of-range vital signs may be repeated once.
History or presence of allergic or adverse response to pretomanid or related drugs.
Use of any drugs or treatment with any known drugs that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) and/or P-gp, including St. John's Wort, within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
Female with a positive pregnancy test result.
Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.

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Hemoglobin <10.0 g/dL.
ALT (alanine transaminase) or AST (aspartate aminotransferase) >2.0 x the upper limit of normal (ULN).
Hyperbilirubinemia >1.5 x ULN.
History or presence of alcoholism or drug abuse within the past 2 years as determined by the Investigator to be clinically relevant.
Any clinically significant electrocardiogram abnormality at Screening (as deemed by decision of the Investigator and the Study Sponsor's Medical Monitor).
QTcF interval >450 msec for males or >470 msec for females at screening, Day -1, or Day 1 (pre-dose), or history of prolonged QT syndrome.
Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer).

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.

Read the detailed description

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.

Conditions: Multi-drug Resistant Tuberculosis
Being tested: Pretomanid
Keywords: MDR-TB (multi-drug resistant tuberculosis), Extensively Resistant Pulmonary Tuberculosis, XDR-TB (extensively drug resistant tuberculosis), pretomanid, PA-824
Medical subject headings: Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis

What participants receive

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

PretomanidDrug
Also called PA-824
1. Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2. Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3. Treatment C (test) = single 50-mg dispersible tablet, orally administered.
4. Treatment D (test) = single 10-mg dispersible tablet, orally administered.

Study groups in NCT04309656
Study group	Role	What they receive
Panel 1: Pretomanid after meal	Experimental	Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 1 will receive a meal before dosing. Receives: Drug: Pretomanid
Panel 2: Pretomanid after fast	Experimental	Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 2 will fast before dosing. Receives: Drug: Pretomanid

What is being measured

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

Relative Bioavailability - Cmax
Relative bioavailability will be determined separately for each panel using Cmax
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Relative Bioavailability - AUC 0-t
Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h*ng/mL)
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Relative Bioavailability - AUC 0-inf
Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose

Secondary outcomes (4)

Food Effect - Ratio of Cmax Fed Vs Fasted
Food effect on bioavailability will be determined across panels using Cmax.
Reported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL)
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Food Effect - Ratio of AUC 0-t Fed Vs Fasted
Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect.
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Food Effect - Ratio of AUC 0-inf Fed Vs Fasted
Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect
Measured: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Adverse Events - Overall Incidence
All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including
Measured: throughout the study, approximately 33 days

Timeline

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

14 Jan 202028 Feb 2020

First posted16 Mar 2020
Study start14 Jan 2020
Primary completion28 Feb 2020
Study completion28 Feb 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04309656
Sponsor's protocol ID: Pa-824-CL-011
Status last verified: Jul 2024
First submitted: 23 Jan 2020
Last updated: 24 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Zou Y, Nedelman J, Lombardi A, Pappas F, Karlsson MO, Svensson EM. Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling. Clin Pharmacokinet. 2022 Nov;61(11):1585-1593. doi: 10.1007/s40262-022-01163-w. Epub 2022 Sep 30.
PubMed 36180816

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?

See locations

Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
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RecruitingObservational study
Bioneer Q-RFIA Clinical Evaluation
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All Multi-drug Resistant Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid
ClinicalTrials.gov ID: NCT04309656
Acronym / sponsor ID: Pa-824-CL-011
Conditions: Multi-drug Resistant Tuberculosis
Keywords: MDR-TB (multi-drug resistant tuberculosis), Extensively Resistant Pulmonary Tuberculosis, XDR-TB (extensively drug resistant tuberculosis), pretomanid, PA-824
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Global Alliance for TB Drug DevelopmentUniversity, hospital or other
Study start: 14 Jan 2020 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 16 Mar 2020 (actual)
Results: Posted 24 Jul 2024

Clinical summary

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

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.

Arm	Type	Receives
Panel 1: Pretomanid after meal	Experimental	Drug: PretomanidEach participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 1 will receive a meal before dosing.
Panel 2: Pretomanid after fast	Experimental	Drug: PretomanidEach participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 2 will fast before dosing.

Who may qualify

Ages: 19 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female. Females must not be pregnant or breastfeeding.
Willing and able to comply with the contraception requirements.
Between 19 and 50 years of age (inclusive) at the time of screening.
Body mass index (BMI) between 18.50 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.

Key exclusion criteria (13 listed)

History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
Vital signs at screening (measured sitting after a minimum 3 minutes rest) as follows: blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg or a heart rate lower than 40 bpm or higher than 99 bpm. Out-of-range vital signs may be repeated once.
History or presence of allergic or adverse response to pretomanid or related drugs.
Use of any drugs or treatment with any known drugs that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) and/or P-gp, including St. John's Wort, within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
Female with a positive pregnancy test result.

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
PretomanidAlso: PA-8241. Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2. Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3. Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4. Treatment D (test) = single 10-mg dispersible tablet, orally administered.	Drug	Panel 1: Pretomanid after meal, Panel 2: Pretomanid after fast

Primary outcome

Relative Bioavailability - Cmax
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Relative bioavailability will be determined separately for each panel using Cmax
Relative Bioavailability - AUC 0-t
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h*ng/mL)
Relative Bioavailability - AUC 0-inf
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)

4 secondary outcomes

Food Effect - Ratio of Cmax Fed Vs Fasted
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Food Effect - Ratio of AUC 0-t Fed Vs Fasted
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Food Effect - Ratio of AUC 0-inf Fed Vs Fasted
Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Adverse Events - Overall Incidence
Time frame: throughout the study, approximately 33 days

Results and safety

Results posted to the registry on 24 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel 1: Pretomanid After Meal	24	24
Panel 2: Pretomanid After Fast	24	24

Primary outcome: Relative Bioavailability - Cmax

Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Panel 1: Pretomanid After Meal n = 24	Panel 2: Pretomanid After Fast n = 24
Treatment A	2170 (484)	1180 (401)
Treatment B	1850 (354)	1090 (334)
Treatment C	389 (58.8)	427 (111)
Treatment D	76.7 (14.2)	110 (20.2)

Panel 1: Pretomanid After Meal: Geometric mean ratio (%): 85.85 (90% CI 81.21 to 90.75), p = 0.0001, ANOVA
Panel 2: Pretomanid After Fast: Geometric mean ratio (%): 92.99 (90% CI 82.65 to 104.62), p = 0.3001, ANOVA

Population analysed: Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles

Primary outcome: Relative Bioavailability - AUC 0-t

Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Panel 1: Pretomanid After Meal n = 24	Panel 2: Pretomanid After Fast n = 24
Treatment A	54900 (10700)	32900 (7580)
Treatment B	55200 (10800)	30200 (9030)
Treatment C	12300 (2790)	10900 (3150)
Treatment D	2040 (514)	2460 (513)

Panel 1: Pretomanid After Meal: Geometric mean ratio (%): 100.60 (90% CI 98.23 to 103.03), p = 0.6686, ANOVA
Panel 2: Pretomanid After Fast: Geometric mean ratio (%): 89.70 (90% CI 81.20 to 99.10), p = 0.0745, ANOVA

Primary outcome: Relative Bioavailability - AUC 0-inf

Time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Panel 1: Pretomanid After Meal n = 24	Panel 2: Pretomanid After Fast n = 24
Treatment A	57400 (12300)	34700 (8330)
Treatment B	57900 (12400)	31900 (10200)
Treatment C	12700 (3210)	11400 (3440)
Treatment D	2100 (552)	2530 (551)

Panel 1: Pretomanid After Meal: Geometric mean ratio (%): 101.03 (90% CI 98.65 to 103.47), p = 0.4683, ANOVA
Panel 2: Pretomanid After Fast: Geometric mean ratio (%): 89.63 (90% CI 81.10 to 99.05), p = 0.0734, ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 33. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel 1: Treatment A	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Panel 1: Treatment B	0 of 24 (0%)	9 of 24 (37.5%)	0 of 24
Panel 1: Treatment C	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Panel 1: Treatment D	0 of 24 (0%)	6 of 24 (25%)	0 of 24
Panel 2:Treatment A	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Panel 2: Treatment B	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Panel 2: Treatment C	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Panel 2: Treatment D	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36180816Zou Y, Nedelman J, Lombardi A, Pappas F, Karlsson MO, Svensson EM. Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling. Clin Pharmacokinet. 2022 Nov;61(11):1585-1593. doi: 10.1007/s40262-022-01163-w. Epub 2022 Sep 30.

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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.

Antonio Lombardi, MD study director

TB Alliance

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 Pretomanid in people with Multi-drug Resistant Tuberculosis, run by Global Alliance for TB Drug Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). 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?

Relative Bioavailability - Cmax (time frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose). The study lists 3 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 NCT04309656, which also lists 1 linked publication.

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 24 Jul 2024.