Cocaine Use DisorderPhase 1NCT04771143
Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056
A Phase 1 study testing AFQ056 in people with Cocaine Use Disorder, run by Novartis Pharmaceuticals.
Trial summary
This is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- AFQ056
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2021to 3 Jan 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-treatment seeking participants who meet DSM-V criteria for cocaine use disorder as assessed using the Mini International Neuropsychiatric Interview (MINI) neuropsychiatric interview (version 7.0).
- Be between 18 and 55 years of age, inclusive
- Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
- Have experience using cocaine by the smoked or IV route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.
- Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
Who cannot join
- Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
- Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.
- Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.
- Be pregnant or lactating.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from at least 30 days prior to the first administration of study treatment (Day -2), while taking study treatment, and for at least 30 days after the last dose of the study treatment.
- Have a systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg and heart rate > 100 beats per minute at screening or clinic intake (Day -3).
- Have a history of liver or renal disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine, 1.5 × the upper limit of normal at screening or intake (Day -3).
About this study
Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, and Potential Interactions of Oral AFQ056 Given Concurrently With Cocaine
This is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder.
Read the detailed description
This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group study to assess safety and tolerability and to compare the effects of AFQ056 on IV cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced participants who meet American Psychiatric Association Diagnostic and Statistical Manual (DSM-V) criteria for cocaine use disorder.
Approximately twenty participants will be randomized to 2 groups (10 in each group), receiving either AFQ056 or placebo treatment for 8 days.
Participants will be screened for eligibility as outpatients and inpatients. Outpatient screening will occur between Day -28 and Day -4. On Study Day -3, participants will undergo clinic intake to screen for continued eligibility. On Study Day -2, participants will be screened for eligibility with a participant-blinded screening infusion (Infusion Session 1) of 20 mg cocaine, followed by a saline infusion, followed by a 40 mg cocaine infusion. Each 2 ml infusion of cocaine and saline will be administered by IV over a 60 second time period and approximately 60 minutes apart. Physiological and subjective data (VAS) from these sessions will be part of the eligibility criteria to continue in the study.
Once a participant has been determined to be eligible, the participant will be randomized on Day -1 to receive either AFQ056 or placebo in a 1:1: ratio and at the same time, will also be randomized to a specific couple of sequences saline/cocaine or cocaine/saline for Infusion Session 2 and Infusion Session 3 within each treatment group. The order of the saline and cocaine infusions for each participant for Infusion Sessions 4 and 5 will be the same as the randomized order for Infusion Sessions 2 and 3, respectively.
Participants will receive baseline infusions determined by the randomized sequences of saline and 20 mg of cocaine on Day 1 (Infusion Session 2) and saline and 40 mg of cocaine on Day 2 (Infusion Session 3). The participants will receive either AFQ056 or matching placebo twice a day from Days 3 to 9. The AFQ056 treatment group will be up titrated to 200 mg according to the following dosing schedule: Day 3: 50 mg twice daily; Day 4: 100 mg twice daily and Days 5-9: 200 mg twice daily. On Day 10, participants will be administered only the morning dose of AFQ056 200 mg or placebo. AFQ056 doses must be taken within 30 minutes of meals. On Day 9 and Day 10, approximately 4 hours after the morning dose of AFQ056 200 mg or placebo, participants will receive treatment infusions determined by the randomized sequence of saline and 20 mg of cocaine on Day 9 (Infusion Session 4) and saline and 40 mg of cocaine on Day 10 (Infusion Session 5). The participants will be discharged from the research clinic on Day 12, two days after the last infusion of cocaine (Infusion Session 5) and will have a Follow-up visit between 7 and 14 days after clinic discharge. A safety follow-up call will be conducted 30 days following the last administration of study treatment on Day 40.
- Conditions
- Cocaine Use Disorder
- Being tested
- AFQ056, Placebo
- Keywords
- safety, tolerability, interaction, cocaine, cocaine use disorder, AFQ056
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
oral administration
PlaceboDrug
matching placebo for oral administration
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 | Experimental | Experimental study drug Receives: Drug: AFQ056 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events
The distribution of adverse events (AEs) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: up to 26 days post-drug administration with a 30-day safety follow-up call
Secondary outcomes (17)
Observed maximum plasma concentration (Cmax) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-t) will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Time of maximum observed drug concentration occurrence (Tmax) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Terminal rate constant (λz) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. λz will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Terminal elimination half-life (T^1/2) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Total systemic clearance for intravenous administration (CL) for cocaine and benzoylecgonine (BE)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics.
Measured: Day 2, Day 10
Observed maximum plasma concentration (Cmax) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Measured: Day 10
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-t) will be listed and summarized using descriptive statistics.
Measured: Day 10
Area Under the plasma concentration-time Curve From 0 To 12 Hours (AUC0-12) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC0-12 will be listed and summarized using descriptive statistics.
Measured: Day 10
Time of maximum observed drug concentration occurrence (Tmax) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Measured: Day 10
Trough plasma concentration (Ctrough) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Ctrough will be listed and summarized using descriptive statistics.
Measured: Day 10
Terminal elimination half-life (T^1/2) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics.
Measured: Day 10
Terminal rate constant (λz) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. λz will be listed and summarized using descriptive statistics.
Measured: Day 10
Apparent clearance of the drug from plasma after oral administration (CL/F) for AFQ056
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL/F will be listed and summarized using descriptive statistics.
Measured: Day 10
Visual Analog Scales (VAS)
The VAS is a self-administered assessment evaluating the subjective effects of cocaine. Participants will use an electronic patient reported outcomes (ePRO) system to answer VAS.
Measured: up through day 10
Brief Substance Craving Scale (BSCS)
The BSCS is a self-administered assessment that asks the participant to rate his or her craving for cocaine. the BSCS used for this study is a modification of the State of Feelings and Cravings Questionnaire. Participants will use an electronic patient reported outcomes (ePRO) system to answer BSCS.
Measured: up through Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start21 Jul 2021 (estimated)
- Primary completion3 Jan 2022 (estimated)
- Study completion3 Jan 2022 (estimated)
Why it stopped: study terminated/withdrawn before FPFV (no patients enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Participants will undergo a screening infusion session with saline and cocaine on Day -2 as part of the eligibility determination. Once deemed eligible, participants will undergo screening infusion sessions 2 and 3 on Days 1 and 2 respectively. Starting Day 3, participants will receive either AFQ056 or matching placebo twice a day from Day 3 to Day 9. The AFQ056 treatment group will be up titrated to 200 mg according to the following dosing schedule: Day 3: 50 mg twice daily; Day 4: 100 mg twice daily and Days 5-9: 200 mg twice daily. On Day 10, participants will be administered only the morning dose of AFQ056 200 mg or placebo. On Days 9 and 10, participants will have infusion session 4 and 5 respectively. The participants will be discharged from the clinic on Day 12 and return for a follow-up visit between 7 to 14 days after clinic discharge. A safety follow-up call will be conducted on Day 40.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771143
- Sponsor's protocol ID
- CAFQ056A02101
- Status last verified
- Jun 2021
- First submitted
- 24 Feb 2021
- Last updated
- 1 Jul 2021
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, and Potential Interactions of Oral AFQ056 Given Concurrently With Cocaine
- ClinicalTrials.gov ID
- NCT04771143
- Acronym / sponsor ID
- CAFQ056A02101
- Conditions
- Cocaine Use Disorder
- Keywords
- safety, tolerability, interaction, cocaine, cocaine use disorder, AFQ056
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study terminated/withdrawn before FPFV (no patients enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Jul 2021 (estimated)
- Primary completion
- 3 Jan 2022 (estimated)
- Study completion
- 3 Jan 2022 (estimated)
- First posted
- 25 Feb 2021 (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 is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder.
Detailed description
This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group study to assess safety and tolerability and to compare the effects of AFQ056 on IV cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced participants who meet American Psychiatric Association Diagnostic and Statistical Manual (DSM-V) criteria for cocaine use disorder.
Approximately twenty participants will be randomized to 2 groups (10 in each group), receiving either AFQ056 or placebo treatment for 8 days.
Participants will be screened for eligibility as outpatients and inpatients. Outpatient screening will occur between Day -28 and Day -4. On Study Day -3, participants will undergo clinic intake to screen for continued eligibility. On Study Day -2, participants will be screened for eligibility with a participant-blinded screening infusion (Infusion Session 1) of 20 mg cocaine, followed by a saline infusion, followed by a 40 mg cocaine infusion. Each 2 ml infusion of cocaine and saline will be administered by IV over a 60 second time period and approximately 60 minutes apart. Physiological and subjective data (VAS) from these sessions will be part of the eligibility criteria to continue in the study.
Once a participant has been determined to be eligible, the participant will be randomized on Day -1 to receive either AFQ056 or placebo in a 1:1: ratio and at the same time, will also be randomized to a specific couple of sequences saline/cocaine or cocaine/saline for Infusion Session 2 and Infusion Session 3 within each treatment group. The order of the saline and cocaine infusions for each participant for Infusion Sessions 4 and 5 will be the same as the randomized order for Infusion Sessions 2 and 3, respectively.
Participants will receive baseline infusions determined by the randomized sequences of saline and 20 mg of cocaine on Day 1 (Infusion Session 2) and saline and 40 mg of cocaine on Day 2 (Infusion Session 3). The participants will receive either AFQ056 or matching placebo twice a day from Days 3 to 9. The AFQ056 treatment group will be up titrated to 200 mg according to the following dosing schedule: Day 3: 50 mg twice daily; Day 4: 100 mg twice daily and Days 5-9: 200 mg twice daily. On Day 10, participants will be administered only the morning dose of AFQ056 200 mg or placebo. AFQ056 doses must be taken within 30 minutes of meals. On Day 9 and Day 10, approximately 4 hours after the morning dose of AFQ056 200 mg or placebo, participants will receive treatment infusions determined by the randomized sequence of saline and 20 mg of cocaine on Day 9 (Infusion Session 4) and saline and 40 mg of cocaine on Day 10 (Infusion Session 5). The participants will be discharged from the research clinic on Day 12, two days after the last infusion of cocaine (Infusion Session 5) and will have a Follow-up visit between 7 and 14 days after clinic discharge. A safety follow-up call will be conducted 30 days following the last administration of study treatment on Day 40.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will undergo a screening infusion session with saline and cocaine on Day -2 as part of the eligibility determination. Once deemed eligible, participants will undergo screening infusion sessions 2 and 3 on Days 1 and 2 respectively. Starting Day 3, participants will receive either AFQ056 or matching placebo twice a day from Day 3 to Day 9. The AFQ056 treatment group will be up titrated to 200 mg according to the following dosing schedule: Day 3: 50 mg twice daily; Day 4: 100 mg twice daily and Days 5-9: 200 mg twice daily. On Day 10, participants will be administered only the morning dose of AFQ056 200 mg or placebo. On Days 9 and 10, participants will have infusion session 4 and 5 respectively. The participants will be discharged from the clinic on Day 12 and return for a follow-up visit between 7 to 14 days after clinic discharge. A safety follow-up call will be conducted on Day 40.
| Arm | Type | Receives |
|---|---|---|
| AFQ056 | Experimental | Drug: AFQ056Experimental study drug |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-treatment seeking participants who meet DSM-V criteria for cocaine use disorder as assessed using the Mini International Neuropsychiatric Interview (MINI) neuropsychiatric interview (version 7.0).
- Be between 18 and 55 years of age, inclusive
- Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
- Have experience using cocaine by the smoked or IV route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.
- Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
Key exclusion criteria (7 listed)
- Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
- Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.
- Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.
- Be pregnant or lactating.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from at least 30 days prior to the first administration of study treatment (Day -2), while taking study treatment, and for at least 30 days after the last dose of the study treatment.
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 |
|---|---|---|
| AFQ056oral administration | Drug | AFQ056 |
| Placebomatching placebo for oral administration | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: up to 26 days post-drug administration with a 30-day safety follow-up call
The distribution of adverse events (AEs) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
17 secondary outcomes
Observed maximum plasma concentration (Cmax) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Time of maximum observed drug concentration occurrence (Tmax) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Terminal rate constant (λz) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Terminal elimination half-life (T^1/2) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Total systemic clearance for intravenous administration (CL) for cocaine and benzoylecgonine (BE)
Time frame: Day 2, Day 10
Observed maximum plasma concentration (Cmax) for AFQ056
Time frame: Day 10
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for AFQ056
Time frame: Day 10
Area Under the plasma concentration-time Curve From 0 To 12 Hours (AUC0-12) for AFQ056
Time frame: Day 10
Time of maximum observed drug concentration occurrence (Tmax) for AFQ056
Time frame: Day 10
Trough plasma concentration (Ctrough) for AFQ056
Time frame: Day 10
Terminal elimination half-life (T^1/2) for AFQ056
Time frame: Day 10
Terminal rate constant (λz) for AFQ056
Time frame: Day 10
Apparent clearance of the drug from plasma after oral administration (CL/F) for AFQ056
Time frame: Day 10
Visual Analog Scales (VAS)
Time frame: up through day 10
Brief Substance Craving Scale (BSCS)
Time frame: up through Day 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFQ056 in people with Cocaine Use Disorder, run by Novartis Pharmaceuticals.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with Treatment Emergent Adverse Events (time frame: up to 26 days post-drug administration with a 30-day safety follow-up call). 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 1 Jul 2021.