HealthyPhase 1NCT02823171
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
A Phase 1 study testing Treatment A: 400 mg Pacritinib P3CT and Treatment B: 400 mg of pacritinib FMI in people with Healthy, run by CTI BioPharma at 1 site in United States.
Trial summary
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral Administration in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A: 400 mg Pacritinib P3CT and Treatment B: 400 mg of pacritinib FMI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females, aged 18 to 55 years, inclusive, who are not tobacco users;
- with BMI in the range of 18.0 to 32.0 kg/m2, inclusive;
- in good health, determined by no clinically significant findings from medical history, physical examination, and vital signs as determined by the Investigator, in consultation with the sponsor;
- normal 12-lead ECG, or ECG findings (including RR, PR, and QT intervals; QT interval corrected using Fridericia's formula [QTcF]; QRS duration; and ventricular heart rate) deemed not clinically significant by the Investigator, in consultation with the Sponsor;
- clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator, in consultation with the Sponsor; laboratory values may be confirmed by repeat;
- negative test for selected drugs of abuse (including alcohol) at Screening and at Check-in (Day -1 of Period 1);
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- negative hepatitis panel (including HBsAg and anti-HCV) and negative HIV antibody screens;
- females of childbearing potential must not be pregnant or lactating, and must agree to use 1 of the following forms of contraception from the time of signing the informed consent or 10 days prior to Check-in (Day -1) of Period 1 until 30 days after the final dose administration: non-hormonal intrauterine device (IUD) with spermicide; female condom with spermicide; contraceptive sponge with spermicide; intravaginal system (eg, NuvaRing®); diaphragm with spermicide; cervical cap with spermicide; male sexual partner who agrees to use a male condom with spermicide; sterile sexual partner; or abstinence. Oral, implantable, transdermal, or injectable hormonal contraceptives may not be used from the time of signing the informed consent or 10 days prior to Check-in (Day -1) of Period 1 until 14 days after the final dose administration. For all females, the pregnancy test result must be negative at Screening and Check-in (Day -1) of Period 1. Females not of childbearing potential must be postmenopausal for at least 1 year or surgically sterile (eg, tubal ligation, hysterectomy) for at least 90 days;
- males will be surgically sterile (ie, vasectomy, documented in the medical record by a physician) or agree to use, from Check-in (Day -1) of Period 1 until 90 days following Study Completion/ET, 1 of the following approved methods of contraception: male condom with spermicide; sterile sexual partner; or use by female sexual partner of an IUD with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives. Subjects must agree to refrain from sperm donation from Check-in (Day -1) of Period 1 until 90 days following Study Completion/ET;
- able to comprehend and willing to sign an Informed Consent Form (ICF)
Who cannot join
- prior ingestion of pacritinib;
- history or clinical manifestation of clinically significant cardiovascular, pulmonary, hepatic (eg, hepatitis), renal, hematologic, gastrointestinal (eg, celiac disease, peptic ulcer, gastroesophageal reflux, inflammatory bowel disease), metabolic, allergic, dermatological, neurological, or psychiatric disorder (as determined by the Investigator; appendectomy and cholecystectomy are not considered to be clinically significant events);
- significant abnormalities in liver function tests (alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >1.5 × upper limit of normal [ULN]; gamma-glutamyl transferase >2 × ULN; or total bilirubin >1.3 × ULN) or kidney function tests (serum creatinine > ULN) that are considered clinically significant by the Investigator; laboratory values may be confirmed by repeat;
- history of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps;
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator in consultation with the Sponsor;
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, cholecystectomy, and hernia repair will be allowed;
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- history of Gilbert's Syndrome;
- history or presence of ECG QTcF >450 msec, factors that increase risk for QTc interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome);
- history of alcoholism or drug addiction within 1 year prior to Check-in (Day -1) of Period 1;
- use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) of Period 1 and during the entire study;
- consumption of alcohol- or caffeine-containing foods and beverages for 72 hours prior to Screening and during the entire study;
- consumption of grapefruit-containing foods and beverages or other CYP3A4 inhibitors or inducers for 72 hours prior to Screening and during the entire study;
- subjects will refrain from strenuous exercise from 48 hours prior to Check-in (Day -1) of Period 1 and during the period of confinement at the CRU and will otherwise maintain their normal level of physical activity throughout the entire study (ie, will not begin a new exercise program nor participate in any unusually strenuous physical exertion);
- participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days prior to Check-in (Day -1) of Period 1, whichever is longer, and during the entire study;
- female subjects who are unable to refrain from the use of oral, implantable, injectable, or transdermal hormonal contraceptives within 10 days prior to Check-in (Day -1) of Period 1 or from the time of signing the informed consent until 14 days after the final dose administration;
- use of any prescription medications and/or products within 14 days prior to Check-in (Day -1) of Period 1 and during the entire study, unless deemed acceptable by the Investigator, in consultation with the Sponsor;
- use of any over-the-counter, non-prescription medications (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in (Day -1) of Period 1 and during the entire study, unless deemed acceptable by the Investigator, in consultation with the Sponsor;
- poor peripheral venous access;
- donation of blood from 30 days prior to Screening through Study Completion/ET, inclusive, or plasma from 2 weeks prior to Screening through Study Completion/ET, inclusive;
- receipt of blood products within 2 months prior to Check-in (Day -1) of Period 1;
- any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710
About this study
Official title: A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral Administration in Healthy Subjects
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral Administration in Healthy Subjects
Read the detailed description
This study will be a Phase 1, open-label, single-dose, randomized, 2-period, 2-treatment sequence crossover study to determine the bioequivalence of pacritinib following administration of 400-mg doses of P3CT (Reference) and FMI (Test) formulations and to characterize the PK of pacritinib.
Each subject will receive 2 treatments (a 400-mg oral dose of four 100-mg pacritinib P3CT [reference] formulation capsules and a 400-mg oral dose of four 100-mg pacritinib FMI [test] formulation capsules) in a 2-period crossover design. Each treatment will be administered as monotherapy during 1 of 2 treatment periods. A 9-day washout will separate the 2 administrations of study medication. Subjects will remain confined to the Clinical Research Unit (CRU) throughout the study for safety observation and PK blood sample collection
- Conditions
- Healthy
- Being tested
- Treatment A: 400 mg Pacritinib P3CT, Treatment B: 400 mg of pacritinib FMI
- Keywords
- Bioequivalence Study, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: 400 mg Pacritinib P3CTDrug
Also called PAC400mg P3CT
400-mg oral dose of pacritinib P3CT (reference) formulation capsules
Treatment B: 400 mg of pacritinib FMIDrug
Also called PAC400mg FMI
400-mg oral dose of pacritinib FMI (test) formulation capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence I | Experimental | Sequence I: treatment A/B Receives: Drug: Treatment A: 400 mg Pacritinib P3CT; Drug: Treatment B: 400 mg of pacritinib FMI |
| Sequence II | Experimental | Sequence II: treatment B/A Receives: Drug: Treatment A: 400 mg Pacritinib P3CT; Drug: Treatment B: 400 mg of pacritinib FMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The apparent total body clearance (CL/F)
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The maximum plasma concentration (Cmax).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The area under the plasma concentration-time curve from time zero to time of the last measured concentration above the limit of quantification (AUC0-t).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The area under the plasma concentration-time curve from zero to infinity (AUC0-∞).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The time to reach maximum plasma concentration (tmax).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The apparent volume of distribution (Vd)
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of pacritinib 400 mg
Measured: Day 1 to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Kelly Whitehurst, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823171
- Sponsor's protocol ID
- PAC108
- Status last verified
- Jun 2016
- First submitted
- 3 May 2016
- Last updated
- 15 Sep 2023
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02823171
- Acronym / sponsor ID
- PAC108
- Conditions
- Healthy
- Keywords
- Bioequivalence Study, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jul 2016 (estimated)
- 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.
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral Administration in Healthy Subjects
Detailed description
This study will be a Phase 1, open-label, single-dose, randomized, 2-period, 2-treatment sequence crossover study to determine the bioequivalence of pacritinib following administration of 400-mg doses of P3CT (Reference) and FMI (Test) formulations and to characterize the PK of pacritinib.
Each subject will receive 2 treatments (a 400-mg oral dose of four 100-mg pacritinib P3CT [reference] formulation capsules and a 400-mg oral dose of four 100-mg pacritinib FMI [test] formulation capsules) in a 2-period crossover design. Each treatment will be administered as monotherapy during 1 of 2 treatment periods. A 9-day washout will separate the 2 administrations of study medication. Subjects will remain confined to the Clinical Research Unit (CRU) throughout the study for safety observation and PK blood sample collection
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence I | Experimental | Drug: Treatment A: 400 mg Pacritinib P3CT, Drug: Treatment B: 400 mg of pacritinib FMISequence I: treatment A/B |
| Sequence II | Experimental | Drug: Treatment A: 400 mg Pacritinib P3CT, Drug: Treatment B: 400 mg of pacritinib FMISequence II: treatment B/A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- males or females, aged 18 to 55 years, inclusive, who are not tobacco users;
- with BMI in the range of 18.0 to 32.0 kg/m2, inclusive;
- in good health, determined by no clinically significant findings from medical history, physical examination, and vital signs as determined by the Investigator, in consultation with the sponsor;
- normal 12-lead ECG, or ECG findings (including RR, PR, and QT intervals; QT interval corrected using Fridericia's formula [QTcF]; QRS duration; and ventricular heart rate) deemed not clinically significant by the Investigator, in consultation with the Sponsor;
- clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator, in consultation with the Sponsor; laboratory values may be confirmed by repeat;
Key exclusion criteria (21 listed)
- prior ingestion of pacritinib;
- history or clinical manifestation of clinically significant cardiovascular, pulmonary, hepatic (eg, hepatitis), renal, hematologic, gastrointestinal (eg, celiac disease, peptic ulcer, gastroesophageal reflux, inflammatory bowel disease), metabolic, allergic, dermatological, neurological, or psychiatric disorder (as determined by the Investigator; appendectomy and cholecystectomy are not considered to be clinically significant events);
- significant abnormalities in liver function tests (alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >1.5 × upper limit of normal [ULN]; gamma-glutamyl transferase >2 × ULN; or total bilirubin >1.3 × ULN) or kidney function tests (serum creatinine > ULN) that are considered clinically significant by the Investigator; laboratory values may be confirmed by repeat;
- history of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps;
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator in consultation with the Sponsor;
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 |
|---|---|---|
| Treatment A: 400 mg Pacritinib P3CTAlso: PAC400mg P3CT400-mg oral dose of pacritinib P3CT (reference) formulation capsules | Drug | Sequence I, Sequence II |
| Treatment B: 400 mg of pacritinib FMIAlso: PAC400mg FMI400-mg oral dose of pacritinib FMI (test) formulation capsules | Drug | Sequence I, Sequence II |
Primary outcome
The apparent total body clearance (CL/F)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
The maximum plasma concentration (Cmax).
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
The area under the plasma concentration-time curve from time zero to time of the last measured concentration above the limit of quantification (AUC0-t).
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
The area under the plasma concentration-time curve from zero to infinity (AUC0-∞).
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
The time to reach maximum plasma concentration (tmax).
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
The apparent volume of distribution (Vd)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 17
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 15 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
Kelly Whitehurst, MD principal investigator
Covance Clinical Research Unit
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 Treatment A: 400 mg Pacritinib P3CT and Treatment B: 400 mg of pacritinib FMI in people with Healthy, run by CTI BioPharma 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 10 inclusion and 21 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 15 Sep 2023. 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?
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?
The apparent total body clearance (CL/F) (time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose). The study lists 6 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 15 Sep 2023.