Healthy VolunteersPhase 1NCT05965219
A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants
A Phase 1 study testing Emraclidine, Itraconazole and Carbamazepine in people with Healthy Volunteers, run by Cerevel Therapeutics, LLC at 1 site in United States.
Trial summary
The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Emraclidine, Itraconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 10 Nov 2023
- 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
- Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
- Body mass index of 18.5 to 35.0 kilograms per square meter (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]).
- Male and female (women of nonchildbearing potential only) participants, ages 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Male and female (women of nonchildbearing potential only) participants, ages 18 to 55 years, inclusive, at the time of signing the ICF.
- Male and female (both women of childbearing and nonchildbearing potential) participants, ages 18 to 55 years, inclusive, at the time of signing the ICF.
- Sexually active women of childbearing potential must agree to use at least an acceptable birth control method during the trial and for 7 days after the last dose of IMP. Acceptable birth control methods that result in a failure rate of more than 1% per year include the following:
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- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- Male or female condom with or without spermicide
- Cap, diaphragm, or sponge with spermicide
Who cannot join
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
- "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
- Suicidal Ideation Item 3 (Active Suicidal Ideation With Any Methods [Not Plan] Without Intent to Act)
- Suicidal Ideation Item 4 (Active Suicidal Ideation With Some Intent to Act, Without Specific Plan)
- Suicidal Ideation Item 5 (Active Suicidal Ideation With Specific Plan and Intent)
- Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, or Preparatory Acts/Behavior)
Show all 34Show fewer
- "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
- Suicidal Ideation Item 1 (Wish to be Dead)
- Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts)
- Serious risk of suicide in the opinion of the investigator is also exclusionary.
- Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
- Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
- Positive drug screen (including cotinine and tetrahydrocannabinol [THC]) or a positive test for alcohol.
- History of presence of any of the following and deemed clinically significant by the investigator or designee and confirmed by the medical monitor:
- Ventricular dysfunction or risk factors for torsades de pointes (e.g., heart failure, cardiomyopathy, family history of long-QT syndrome)
- Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > upper limit of normal (ULN).
- Total bilirubin >ULN. If Gilbert's syndrome is suspected, total bilirubin >ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin.
- Hypokalemia (potassium levels < lower limit of normal [LLN] millimoles per liter [mmol/L]), and/or hypomagnesemia (magnesium levels <1.2 milligrams per deciliter [mg/dL]; <0.5 mmol/L), and/or hypocalcemia (corrected serum calcium <8.0 mg/dL or ionized calcium <1.0 mmol/L).
- Participants positive for human leukocyte antigen (HLA)-B*1502 or HLA-A*3101.
- Family history of drug reaction with eosinophilia and systemic symptoms (DRESS).
- Family history of porphyria.
- History of cardiac conduction disturbance including second- and third-degree atrioventricular heart block.
- Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement:
- Platelets, white blood cell count, absolute neutrophil count, or hemoglobin <LLN.
- Serum sodium <LLN.
- Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary:
- AST or ALT >ULN.
- Total bilirubin >ULN. If Gilbert's syndrome is suspected, total bilirubin >ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin.
- Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary:
- AST or ALT ≥2 × ULN.
- Total bilirubin >1.5 × ULN. If Gilbert's syndrome is suspected, total bilirubin >1.5 × ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test result at Check-in.
- [Note: Other inclusion and exclusion criteria as per protocol may apply.]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Three-Part, Fixed-Sequence Trial in Healthy Adult Participants to Evaluate the Effects of Itraconazole and Carbamazepine on the Single-Dose Pharmacokinetics of Emraclidine, and the Effect of Emraclidine on the Single-Dose Pharmacokinetics of Metformin
The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Emraclidine, Itraconazole, Carbamazepine, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Emraclidine tablets.
ItraconazoleDrug
Also called Sporanox
Itraconazole oral solution.
CarbamazepineDrug
Also called Tegretol-XR
Carbamazepine tablets.
MetforminDrug
Also called Glucophage
Metformin tablets.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Emraclidine Followed by Itraconazole + Emraclidine | Experimental | Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2. Receives: Drug: Emraclidine; Drug: Itraconazole |
| Part B: Emraclidine Followed by Carbamazepine + Emraclidine | Experimental | Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2. Receives: Drug: Emraclidine; Drug: Carbamazepine |
| Part C: Metformin Followed by Emraclidine + Metformin | Experimental | Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2. Receives: Drug: Emraclidine; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: Cmax of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: Cmax of Metformin
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUC0-t of Metformin
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUCinf of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUCinf of Metformin
Measured: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Secondary outcomes (6)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity
Measured: From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Measured: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Measured: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Measured: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Measured: Up to end of treatment in each part of the study (up to an average of 15 days)
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Measured: Up to end of treatment in each part of the study (up to an average of 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start15 Aug 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965219
- Sponsor's protocol ID
- CVL-231-HV-1010
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2023
- Last updated
- 2 Apr 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Three-Part, Fixed-Sequence Trial in Healthy Adult Participants to Evaluate the Effects of Itraconazole and Carbamazepine on the Single-Dose Pharmacokinetics of Emraclidine, and the Effect of Emraclidine on the Single-Dose Pharmacokinetics of Metformin
- ClinicalTrials.gov ID
- NCT05965219
- Acronym / sponsor ID
- CVL-231-HV-1010
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 28 Jul 2023 (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.
The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Emraclidine Followed by Itraconazole + Emraclidine | Experimental | Drug: Emraclidine, Drug: ItraconazoleParticipants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2. |
| Part B: Emraclidine Followed by Carbamazepine + Emraclidine | Experimental | Drug: Emraclidine, Drug: CarbamazepineParticipants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2. |
| Part C: Metformin Followed by Emraclidine + Metformin | Experimental | Drug: Emraclidine, Drug: MetforminParticipants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
- Body mass index of 18.5 to 35.0 kilograms per square meter (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]).
- Male and female (women of nonchildbearing potential only) participants, ages 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Male and female (women of nonchildbearing potential only) participants, ages 18 to 55 years, inclusive, at the time of signing the ICF.
- Male and female (both women of childbearing and nonchildbearing potential) participants, ages 18 to 55 years, inclusive, at the time of signing the ICF.
Key exclusion criteria (34 listed)
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
- "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
- "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
- Serious risk of suicide in the opinion of the investigator is also exclusionary.
- Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
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 |
|---|---|---|
| EmraclidineEmraclidine tablets. | Drug | Part A: Emraclidine Followed by Itraconazole + Emraclidine, Part B: Emraclidine Followed by Carbamazepine + Emraclidine, Part C: Metformin Followed by Emraclidine + Metformin |
| ItraconazoleAlso: SporanoxItraconazole oral solution. | Drug | Part A: Emraclidine Followed by Itraconazole + Emraclidine |
| CarbamazepineAlso: Tegretol-XRCarbamazepine tablets. | Drug | Part B: Emraclidine Followed by Carbamazepine + Emraclidine |
| MetforminAlso: GlucophageMetformin tablets. | Drug | Part C: Metformin Followed by Emraclidine + Metformin |
Primary outcome
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: Cmax of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: Cmax of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUC0-t of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUCinf of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUCinf of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
6 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity
Time frame: From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
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 2 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Emraclidine, Itraconazole and Carbamazepine in people with Healthy Volunteers, run by Cerevel Therapeutics, LLC 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 9 inclusion and 34 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 2 Apr 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?
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?
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364 (time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A). The study lists 9 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 2 Apr 2024.