Bladder CancerPhase 1NCT06034015
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
A Phase 1 study testing APL-1202 and APL-1501 (Single ascending dose) and APL-1202 and APL-1501 (Multiple Ascending dose) in people with Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris at 1 site in Australia.
Trial summary
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- APL-1202 and APL-1501 (Single ascending dose) and APL-1202 and APL-1501 (Multiple Ascending dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Sep 2023to 7 Feb 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female 18 to 65 years of age (inclusive at the time of informed consent).
- In good general health, with no significant medical history and no clinically significant abnormalities on physical examination, 12-lead ECG, vital signs and oximetry measurements at Screening and/or before the first administration of Investigational Products (IP), as determined by the Principal Investigator or designee.
- Clinical laboratory values within normal range as specified by the testing laboratory, at Screening and/or before the first administration of IP unless deemed not clinically significant (NCS) by the Principal Investigator or designee.
- Body-mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weight ≥ 50 kg.
- Current non-smoker or casual smoker who used no more than 5 cigarettes (or equivalent quantity of any other nicotine-containing products eg, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes [Vaping] etc.) per week for 3 months prior to Screening. Participants must abstain from smoking and abstain from using nicotine-containing products (eg, nicotine chewing gum, nicotine plasters, or other product used for smoking cessation) for 2 weeks prior to admission and throughout the study period, and test negative at Screening and on Day -1 for urinary cotinine.
- No relevant dietary restrictions.
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- Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 30 days after study completion, including the Follow-up period.
- Males must be surgically sterile (> 90 days since vasectomy with no viable sperm), or if engaged in sexual relations with a women of child bearing potential (WOCBP), his partner must be either surgically sterile (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use an acceptable, highly effective contraceptive method (see Section 7.3.3) from Screening until 90 days after study completion, including the Follow-up period.
- Able and willing to attend the necessary visits to the study site.
- Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Who cannot join
- Underlying physical or psychological medical condition that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- Receipt of blood products, or significant blood loss deemed to be CTCAE Grade 3 or Grade 4 within 6 weeks prior to the first administration of IP.
- Plasma donation within 7 days prior to the first administration of IP, or platelet/blood donation within 4 weeks prior to the first administration of IP
- Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the first administration of IP.
- Poor pill swallowing ability.
- History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents, including lactose intolerance/allergy.
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- History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- History or presence of a condition associated with significant immunosuppression.
- History of life-threatening infection (eg, meningitis). Severe infections within 4 weeks prior to the first administration of IP including but not limited to hospitalisation for complications of infection, bacteraemia, or severe pneumonia.
- Infections requiring parenteral antibiotics within 6 months prior to the first administration of IP.
- Vaccination with a live vaccine within 4 weeks prior to the first administration of IP. COVID-19 or influenza can be exempted.
- Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to the first administration of IP or 5-half-lives, whichever is longer.
- Positive test for hepatitis C virus antibody (HCVAb), hepatitis B virus surface antigen (HBsAg), human Immunodeficiency virus (HIV) antibody, or COVID-19 at Screening and Day-1.
- History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test at Screening or 2 successive indeterminate QuantiFERON-TB Gold test results.
- Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates, cocaine and tricyclic antidepressants), or alcohol breath test at Screening and Day-1.
- History of substance abuse or dependency or history of recreational intravenous drug use over the last 5 years (by self-declaration).
- Regular alcohol consumption defined as > 10 standard drinks per week (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or > 4 standard drinks on any single day. Participant is unwilling to abstain from alcohol beginning 48 hours prior to the first administration of IP and for the duration of the study.
- Use of any IP or investigational medical device within 30 days prior to the first administration of IP, or 5 half-lives of the product (whichever is the longest), or participation in more than 4 investigational drug studies within 1 year prior to the first administration of IP.
- Use of (or anticipated use of) any prescription drugs or over-the-counter (OTC) medication, herbal remedies, supplements or vitamins 2 weeks prior to the first administration of IP and during the course of the study without prior approval of the PI and Medical Monitor (MM). Simple analgesia (paracetamol, nonsteroidal anti-inflammatory drug ) may be permitted at the discretion of the PI. The use of hormonal contraception, oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device (IUD) will be permitted.
- Unwilling to refrain from strenuous exercise (including weightlifting) 48 hours prior to the admission to the clinical research unit (CRU) and 48 hours prior to any outpatient visit.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, ophthalmological or psychiatric disorder, as determined by the PI or designee, if deemed clinically relevant by PI or designee.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs. Uncomplicated appendectomy, uncomplicated cholecystectomy and hernia repair will be allowed as determined by the PI or designee.
- Use or intent to use any medications/products/food known to alter drug absorption, metabolism, or elimination processes, including strong inducers or inhibitors of metabolism enzymes or transporters, including but not limited to St. John's wort, grapefruit, and grapefruit juice, within 14 days prior to the first administration of IP, unless deemed acceptable by the PI or designee.
- A participant who, in the opinion of the PI or designee, should not participate in this study
- Anything that the PI considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of the study data.
- Smoked more than 5 cigarettes per week 3 months prior to Screening.
- Has a positive cotinine at Screening and on Day -1 and or disagreed abstinence from the use of any tobacco products 2 weeks prior to admission to the CRU and throughout the study period.
- Optic nerve disease and cataracts and those with a history of related conditions
- -
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Philip Ryan, Dr, (03) 8593 9800
About this study
Official title: A Phase 1, Two-Part, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers (Part A) and Multiple Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers (Part B)
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
Read the detailed description
The study will have 2 parts: Each study part will comprise 2 dosing periods with a 72-hour washout period in between:
Period 1: APL-1202 IR tablet dosing and Period 2: APL-1501 ER capsule dosing.
In Part A dosing will be single day/single dosing for the APL-1202 IR tablets, and single day/single dosing the APL-1501 ER capsules with 24 participants in 3 sequential cohorts, Cohorts A1, A2, and A3. Each cohort will enrol 8 participants, with male to female participants in a 1:1 ratio. In Period 1/Day 1, participants in all cohorts will be dosed with single dose of 375 mg APL-1202 IR tablets which will followed by a washout period of at least 72 hours, after which participants will be dosed with single dose of APL-1501 ER capsules in Period 2/Day 4, .
In Part B dosing will be multi-day/TID dosing for the APL-1202 IR tablets, and multi-day/BID dosing the APL-1501 ER capsules with 24 participants in 2 sequential cohorts, Cohorts B1 and B2. Each cohort will enrol 12 participants, with male to female participants in a 1:1 ratio and in each of the 2 study periods, participants will be administered IP for 5 days. In period 1, participants will administered with APL-1202 IR tablet (TID) on Day 1, Day 2, Day 3, Day 4, and Day 5 and period 2 with APL-1501 ER capsule (BID) dosing on Day 9, Day 10, Day 11, Day 12, and morning of Day 13.
- Conditions
- Bladder Cancer
- Being tested
- APL-1202 and APL-1501 (Single ascending dose), APL-1202 and APL-1501 (Multiple Ascending dose)
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-1202 and APL-1501 (Single ascending dose)Drug
Period 1 drug adminstration (APL-1202 IR tablet , single dose of 375mg will be administered orally on Day 1; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered as single dose on Day 4.
APL-1202 and APL-1501 (Multiple Ascending dose)Drug
Period 1 drug adminstration (APL-1202 IR of 375mg will be administered thrice a day (TID) orally from Day 1 to Day 5; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered twice daily (BID) from Day 9 to 13.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Active comparator | Not described Receives: Drug: APL-1202 and APL-1501 (Single ascending dose) |
| Part B | Active comparator | Not described Receives: Drug: APL-1202 and APL-1501 (Multiple Ascending dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with AEs
Measured: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Serious Adverse Events (SAEs)
Number of participants with SAEs
Measured: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Treatement Emergent Adverse Events (TEAEs)
Number of participants with TEAEs
Measured: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Secondary outcomes (8)
PK parameters: area under the curve (AUC)
Area under the curve (AUC) of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
PK parameters: maximum concentration (Cmax)
maximum concentration (Cmax), of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
PK parameters: Tmax
Tmax of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
PK parameters: half-life (t1/2)
apparent t1/2 of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
Urine PK parameters: Renal clearance (CLr)
Urine concentration of APL-1202 Tablets.
Measured: up to 120 hours post dose in each treatment period
Urine PK parameters: Total amount of the APL-1202 excreted in urine from time t1 to t2 hours (Aet1-t2)
Urine concentration of APL-1202 Tablets.
Measured: up to 120 hours post dose in each treatment period
PK Parameters: Apparent total plasma clearance (CL/F)
CL/F of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
PK Parameters: Apparent terminal volume of distribution (Vz/F)
Vz/F of APL-1501 ER capsules and APL-1202 IR Tablets
Measured: up to 120 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start9 Sep 2023 (estimated)
- Primary completion19 Jan 2024 (estimated)
- Study completion7 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034015
- Sponsor's protocol ID
- YHGT-PN-02
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers (Part A) and Multiple Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers (Part B)
- ClinicalTrials.gov ID
- NCT06034015
- Acronym / sponsor ID
- YHGT-PN-02
- Conditions
- Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu Yahong Meditech Co., Ltd aka AsierisIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2023 (estimated)
- Primary completion
- 19 Jan 2024 (estimated)
- Study completion
- 7 Feb 2024 (estimated)
- First posted
- 13 Sep 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.
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
Detailed description
The study will have 2 parts: Each study part will comprise 2 dosing periods with a 72-hour washout period in between:
Period 1: APL-1202 IR tablet dosing and Period 2: APL-1501 ER capsule dosing.
In Part A dosing will be single day/single dosing for the APL-1202 IR tablets, and single day/single dosing the APL-1501 ER capsules with 24 participants in 3 sequential cohorts, Cohorts A1, A2, and A3. Each cohort will enrol 8 participants, with male to female participants in a 1:1 ratio. In Period 1/Day 1, participants in all cohorts will be dosed with single dose of 375 mg APL-1202 IR tablets which will followed by a washout period of at least 72 hours, after which participants will be dosed with single dose of APL-1501 ER capsules in Period 2/Day 4, .
In Part B dosing will be multi-day/TID dosing for the APL-1202 IR tablets, and multi-day/BID dosing the APL-1501 ER capsules with 24 participants in 2 sequential cohorts, Cohorts B1 and B2. Each cohort will enrol 12 participants, with male to female participants in a 1:1 ratio and in each of the 2 study periods, participants will be administered IP for 5 days. In period 1, participants will administered with APL-1202 IR tablet (TID) on Day 1, Day 2, Day 3, Day 4, and Day 5 and period 2 with APL-1501 ER capsule (BID) dosing on Day 9, Day 10, Day 11, Day 12, and morning of Day 13.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Active comparator | Drug: APL-1202 and APL-1501 (Single ascending dose) |
| Part B | Active comparator | Drug: APL-1202 and APL-1501 (Multiple Ascending dose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male or female 18 to 65 years of age (inclusive at the time of informed consent).
- In good general health, with no significant medical history and no clinically significant abnormalities on physical examination, 12-lead ECG, vital signs and oximetry measurements at Screening and/or before the first administration of Investigational Products (IP), as determined by the Principal Investigator or designee.
- Clinical laboratory values within normal range as specified by the testing laboratory, at Screening and/or before the first administration of IP unless deemed not clinically significant (NCS) by the Principal Investigator or designee.
- Body-mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weight ≥ 50 kg.
- Current non-smoker or casual smoker who used no more than 5 cigarettes (or equivalent quantity of any other nicotine-containing products eg, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes [Vaping] etc.) per week for 3 months prior to Screening. Participants must abstain from smoking and abstain from using nicotine-containing products (eg, nicotine chewing gum, nicotine plasters, or other product used for smoking cessation) for 2 weeks prior to admission and throughout the study period, and test negative at Screening and on Day -1 for urinary cotinine.
Key exclusion criteria (29 listed)
- Underlying physical or psychological medical condition that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- Receipt of blood products, or significant blood loss deemed to be CTCAE Grade 3 or Grade 4 within 6 weeks prior to the first administration of IP.
- Plasma donation within 7 days prior to the first administration of IP, or platelet/blood donation within 4 weeks prior to the first administration of IP
- Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the first administration of IP.
- Poor pill swallowing ability.
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 |
|---|---|---|
| APL-1202 and APL-1501 (Single ascending dose)Period 1 drug adminstration (APL-1202 IR tablet , single dose of 375mg will be administered orally on Day 1; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered as single dose on Day 4. | Drug | Part A |
| APL-1202 and APL-1501 (Multiple Ascending dose)Period 1 drug adminstration (APL-1202 IR of 375mg will be administered thrice a day (TID) orally from Day 1 to Day 5; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered twice daily (BID) from Day 9 to 13. | Drug | Part B |
Primary outcome
Adverse Events (AEs)
Time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Number of participants with AEs
Serious Adverse Events (SAEs)
Time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Number of participants with SAEs
Treatement Emergent Adverse Events (TEAEs)
Time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
Number of participants with TEAEs
8 secondary outcomes
PK parameters: area under the curve (AUC)
Time frame: up to 120 hours post dose in each treatment period
PK parameters: maximum concentration (Cmax)
Time frame: up to 120 hours post dose in each treatment period
PK parameters: Tmax
Time frame: up to 120 hours post dose in each treatment period
PK parameters: half-life (t1/2)
Time frame: up to 120 hours post dose in each treatment period
Urine PK parameters: Renal clearance (CLr)
Time frame: up to 120 hours post dose in each treatment period
Urine PK parameters: Total amount of the APL-1202 excreted in urine from time t1 to t2 hours (Aet1-t2)
Time frame: up to 120 hours post dose in each treatment period
PK Parameters: Apparent total plasma clearance (CL/F)
Time frame: up to 120 hours post dose in each treatment period
PK Parameters: Apparent terminal volume of distribution (Vz/F)
Time frame: up to 120 hours post dose in each treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
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 APL-1202 and APL-1501 (Single ascending dose) and APL-1202 and APL-1501 (Multiple Ascending dose) in people with Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris at 1 site in Australia.
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 29 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: status not confirmed, as of the sponsor's last update on 13 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 Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiuyue Qu (+86 021 68583863, qyqu@asieris.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.