Hepatic ImpairmentPhase 1NCT04469920
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
A Phase 1 study testing Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Hepatic Impairment, run by Zydus Therapeutics Inc. at 2 sites in United States.
Trial summary
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2020to 21 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to comprehend and willingness to sign a written informed consent for the study.
- Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
- Females of child-bearing potential and Males must agree to use contraception for the full duration of the study.
- Ability to swallow and retain oral medication.
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- Groups 1 through 6 subjects may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the Investigator are eligible.
- Participants with hepatic impairment in Groups 1-4 will be classified at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.
- Laboratory test values for Groups 1-4 hepatic impairment subjects must be clinically acceptable to the Investigator and meet all of the following parameters at Screening:
- ALT/AST value ≤ 10 × upper limit of normal (ULN)
- Absolute neutrophil count (ANC) ≥ 750/mm3
- Platelets ≥ 25,000/mm3
- Hemoglobin ≥ 8 g/dL
- α-fetoprotein < 50 ng/mL or 50-80 ng/mL with concurrent negative imaging study (US, CT, MRI)
- Group 2 must have evidence of PHT as manifested by one of the following:
- presence of hepatic encephalopathy or ascites (on exam or imaging or medication to control these symptoms),
- historical or current presence of varices by imaging or endoscopy,
- historical or current presence of splenomegaly by imaging or physical exam,
- previous Hepatic Venous Pressure Gradient Measurement (HVPG) >10 mmHg,
- platelet count <150,000/mm3 (or /uL), or
- Fibroscan® at screening >20 kPa.
- Documented history of cholestatic liver disease (i.e. primary biliary cholangitis, primary sclerosing cholangitis) OR alkaline phosphatase at screening of >1.25 x ULN with AST/ALT <1.2 x ULN OR Historical presence of AMA (anti-mitochondrial antibody) >1:40 and elevated alkaline phosphatase > ULN at screening
- Clinical diagnosis of NASH and the following criteria:
- Screening Fibroscan® with liver stiffness > 8.5 kPa AND CAP >280 dB AND At least two criteria for metabolic syndrome modified from the NCEP
- ATP III Guidelines, at screening:
- Fasting glucose >100 mg/dL or receiving drug treatment for elevated glucose, ii. Fasting HDL cholesterol <40 mg/dL in men and <50 mg/dL in women or receiving drug treatment for low HDL cholesterol, iii. Fasting triglycerides > 150 mg/dL or receiving drug treatment for hypertriglyceridemia, iv. Waist circumference >102 cm for men or >88 cm for women or BMI >30 kg/m2, v. Systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg or receiving drug treatment for hypertension
- OR:
- A historical liver biopsy within 6 months of screening consistent with NASH with stage 3 fibrosis and no documented weight loss >10% since date of liver biopsy
- Subjects with normal hepatic function must match in age (± 10 years), gender, and weight (± 10 kg) with hepatic disease participants in the Groups 1-6.
- Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in.
- Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT/AST < 1.2 × ULN at screening.
Who cannot join
- Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
- History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).
- History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
- Any major surgery within 3 months of screening.
- Donation of blood or blood products within 3 months prior to screening.
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- Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.
- Receiving or has received any investigational drug within the 30 days or 5 halflives (whichever is longer), before receiving Saroglitazar Magnesium.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 by modification of diet in renal disease (MDRD) formula at screening.
- Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.
- Positive test for drugs of abuse at screening or admission.
- Any subject with poor peripheral venous access
- Receipt of blood products within 1 month prior to check in.
- Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups.
- Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator.
- Electrocardiogram QTcF > 500 msec, confirmed by repeat measurement OR presence of second- or third-degree atrioventricular (AV) block.
- Subjects having -
- History of gastrointestinal bleeding within 1 month prior to screening.
- Current functioning organ transplant.
- Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.
- Subjects having a history of any of the following: hepatic encephalopathy, ascites, history or current presence of varices by imaging or endoscopy, history or current presence of splenomegaly by imaging or physical exam, previous HVPG >10, platelet count <150,000 (or /uL) at screening, or Fibroscan® at screening >20 kPa.
- QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec, confirmed by repeat measurement OR presence of second- or third-degree AV block.
- Hepatitis B virus surface antigen (HBsAg) positive, Hepatitis C virus antibody (HCV-Ab) positive.
- Subjects who use or intend to use any over the counter (vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) or prescription medications within 30 days or 5 half-lives (whichever is longer) prior to enrolment, with the exception of hormone replacement therapy and therapies for hepatic disease and treatments of associated disorders that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the Investigator (or designee).
- Other known cause of liver disease such as NASH, Alcoholic Steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records
- Evidence of liver decompensation such as ascites, hepatic encephalopathy or prior history of variceal bleed.
- No other known cause of liver disease such as Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Alcoholic Steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records
- Platelet count <150,000 (or /uL)
- Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 14 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen, hormonal contraceptive medications and/or any other over-the-counter product approved by the Investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Hepatic Function and with Hepatic Impairment, Cholestatic Liver Disease, NASH with Advanced Fibrosis
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
Read the detailed description
Male and female participants 18-80 years of age (inclusive) with normal hepatic function or hepatic impairment/disease who meet all of the inclusion and none of the exclusion criteria. Subjects with hepatic impairment will be enrolled based upon the Child-Pugh-Turcotte (CPT) classification system for mild hepatic impairment (Group 1 CPT Class A without PHT; Group 2 CPT Class A with PHT), moderate hepatic impairment (Group 3 Decompensated CPT Class B), or severe hepatic impairment (Group 4 Decompensated CPT Class C). Group 5 will include subjects with cholestatic liver disease and Group 6 will include subjects with non-cirrhotic advanced fibrosis secondary to NASH (non-alcoholic steatohepatitis). The control group (Group 7) will consist of demographic matched subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar Magnesium 2 mgDrug
Also called Not any
1 tablet, single dose at Day 1
Saroglitazar Magnesium 4 mgDrug
Also called Not any
1 tablet, single dose at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1- mild hepatic impairment without evidence of PHT | Experimental | Subject with mild hepatic impairment without evidence of portal hypertension (PHT) based on Class A CPT score 5-6 points Receives: Drug: Saroglitazar Magnesium 4 mg |
| Group 2- mild hepatic impairment with evidence of PHT | Experimental | Subjects with mild hepatic impairment with evidence of portal hypertension based on Class A CPT score 5-6 points Receives: Drug: Saroglitazar Magnesium 4 mg |
| Group 3-moderate hepatic impairment | Experimental | Subjects with moderate hepatic impairment based on Class B CPT score 7-9 points Receives: Drug: Saroglitazar Magnesium 4 mg |
| Group 4- severe hepatic impairment | Experimental | Subjects with severe hepatic impairment based on Class C CPT score 10-14 points) Receives: Drug: Saroglitazar Magnesium 4 mg |
| Group 5-cholestatic liver disease | Experimental | Subjects with cholestatic liver disease Receives: Drug: Saroglitazar Magnesium 2 mg; Drug: Saroglitazar Magnesium 4 mg |
| Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH | Experimental | Subjects with Non-cirrhotic Advanced Fibrosis secondary to NASH Receives: Drug: Saroglitazar Magnesium 2 mg; Drug: Saroglitazar Magnesium 4 mg |
| Group 7- normal hepatic function | Experimental | Subjects with normal hepatic function Receives: Drug: Saroglitazar Magnesium 2 mg; Drug: Saroglitazar Magnesium 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from time zero to infinity (AUC0-∞)
The area under the plasma concentration versus time curve from zero to infinity will be calculated by adding Ct/Kel to AUCt, where Ct is the last quantifiable concentration and Kel is the elimination rate constant.
Measured: Before dosing on Day 1 through Day 7
AUC from time zero to the last quantifiable concentration (AUC0-t)
The area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration.
Measured: Before dosing on Day 1 through Day 7
Cmax
Maximum measured plasma concentration over the time span specified.
Measured: Before dosing on Day 1 through Day 7
Tmax
Time of the maximum measured plasma concentration.
Measured: Before dosing on Day 1 through Day 7
t1/2
The half-life will be calculated by the equation tHalf = 0.693/ Kel. Kel (The terminal elimination rate constant) will be obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the natural log of the concentration versus time plot for these points
Measured: Before dosing on Day 1 through Day 7
CL/F
Clearance
Measured: Before dosing on Day 1 through Day 7
Vz/F
Volume of distribution
Measured: Before dosing on Day 1 through Day 7
Secondary outcomes (4)
Urine Pharmacokinetic: Ae
Amount of drug excreted during each collection interval
Measured: Before dosing on Day 1 through Day 5
Incidence of AEs
Incidence and severity of AEs as a measure of safety and tolerability will be measured and reported.
Measured: Before dosing on Day 1 through Day 12
Unbound Fraction
Unbound fraction in plasma of Saroglitazar
Measured: Day 1
Unbound concentration
Unbound concentration in plasma of Saroglitazar
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start16 Jul 2020
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deven Parmar, MD, Study director, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469920
- Sponsor's protocol ID
- SARO.19.003
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Hepatic Function and with Hepatic Impairment, Cholestatic Liver Disease, NASH with Advanced Fibrosis
- ClinicalTrials.gov ID
- NCT04469920
- Acronym / sponsor ID
- SARO.19.003
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
Detailed description
Male and female participants 18-80 years of age (inclusive) with normal hepatic function or hepatic impairment/disease who meet all of the inclusion and none of the exclusion criteria. Subjects with hepatic impairment will be enrolled based upon the Child-Pugh-Turcotte (CPT) classification system for mild hepatic impairment (Group 1 CPT Class A without PHT; Group 2 CPT Class A with PHT), moderate hepatic impairment (Group 3 Decompensated CPT Class B), or severe hepatic impairment (Group 4 Decompensated CPT Class C). Group 5 will include subjects with cholestatic liver disease and Group 6 will include subjects with non-cirrhotic advanced fibrosis secondary to NASH (non-alcoholic steatohepatitis). The control group (Group 7) will consist of demographic matched subjects with normal hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1- mild hepatic impairment without evidence of PHT | Experimental | Drug: Saroglitazar Magnesium 4 mgSubject with mild hepatic impairment without evidence of portal hypertension (PHT) based on Class A CPT score 5-6 points |
| Group 2- mild hepatic impairment with evidence of PHT | Experimental | Drug: Saroglitazar Magnesium 4 mgSubjects with mild hepatic impairment with evidence of portal hypertension based on Class A CPT score 5-6 points |
| Group 3-moderate hepatic impairment | Experimental | Drug: Saroglitazar Magnesium 4 mgSubjects with moderate hepatic impairment based on Class B CPT score 7-9 points |
| Group 4- severe hepatic impairment | Experimental | Drug: Saroglitazar Magnesium 4 mgSubjects with severe hepatic impairment based on Class C CPT score 10-14 points) |
| Group 5-cholestatic liver disease | Experimental | Drug: Saroglitazar Magnesium 2 mg, Drug: Saroglitazar Magnesium 4 mgSubjects with cholestatic liver disease |
| Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH | Experimental | Drug: Saroglitazar Magnesium 2 mg, Drug: Saroglitazar Magnesium 4 mgSubjects with Non-cirrhotic Advanced Fibrosis secondary to NASH |
| Group 7- normal hepatic function | Experimental | Drug: Saroglitazar Magnesium 2 mg, Drug: Saroglitazar Magnesium 4 mgSubjects with normal hepatic function |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Ability to comprehend and willingness to sign a written informed consent for the study.
- Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
- Females of child-bearing potential and Males must agree to use contraception for the full duration of the study.
Key exclusion criteria (30 listed)
- Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
- History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).
- History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
- Any major surgery within 3 months of screening.
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 |
|---|---|---|
| Saroglitazar Magnesium 2 mgAlso: Not any1 tablet, single dose at Day 1 | Drug | Group 5-cholestatic liver disease, Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH, Group 7- normal hepatic function |
| Saroglitazar Magnesium 4 mgAlso: Not any1 tablet, single dose at Day 1 | Drug | Group 1- mild hepatic impairment without evidence of PHT, Group 2- mild hepatic impairment with evidence of PHT, Group 3-moderate hepatic impairment, Group 4- severe hepatic impairment, Group 5-cholestatic liver disease, Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH, Group 7- normal hepatic function |
Primary outcome
AUC from time zero to infinity (AUC0-∞)
Time frame: Before dosing on Day 1 through Day 7
The area under the plasma concentration versus time curve from zero to infinity will be calculated by adding Ct/Kel to AUCt, where Ct is the last quantifiable concentration and Kel is the elimination rate constant.
AUC from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Before dosing on Day 1 through Day 7
The area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration.
Cmax
Time frame: Before dosing on Day 1 through Day 7
Maximum measured plasma concentration over the time span specified.
Tmax
Time frame: Before dosing on Day 1 through Day 7
Time of the maximum measured plasma concentration.
t1/2
Time frame: Before dosing on Day 1 through Day 7
The half-life will be calculated by the equation tHalf = 0.693/ Kel. Kel (The terminal elimination rate constant) will be obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the natural log of the concentration versus time plot for these points
CL/F
Time frame: Before dosing on Day 1 through Day 7
Clearance
Vz/F
Time frame: Before dosing on Day 1 through Day 7
Volume of distribution
4 secondary outcomes
Urine Pharmacokinetic: Ae
Time frame: Before dosing on Day 1 through Day 5
Incidence of AEs
Time frame: Before dosing on Day 1 through Day 12
Unbound Fraction
Time frame: Day 1
Unbound concentration
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Deven Parmar, MD study director
Zydus Therapeutics Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Hepatic Impairment, run by Zydus Therapeutics Inc. at 2 sites 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 31 inclusion and 30 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC from time zero to infinity (AUC0-∞) (time frame: Before dosing on Day 1 through Day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.