Healthy VolunteersPhase 1NCT03919409
First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants
A Phase 1 study testing TS-161 in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.
Trial summary
This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated. 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?
- TS-161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 11 Feb 2020
- 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 adult male and female participants between 18 and 55 years of age, inclusive
- Body weight ≥ 45 kg
- Body Mass Index (BMI) 18 - 30 kg/m^2, inclusive
Who cannot join
- Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
- History or presence of psychiatric or neurologic disease or condition
- History of seizures
- Abnormal EEG observed at screening
- Abnormal blood pressure
- Breast cancer within the past 10 years, or any other malignancies within the past 5 years
Show all 20Show fewer
- Clinically significant abnormal results in electrocardiogram, blood and urine test
- History or presence of liver disease
- Participants using medication or supplements within 14 days prior to dosing
- Use of N-methyl-D-aspartate (NMDA) receptor modulators (example: dextromethorphan, ketamine, amantadine, memantine) within 90 days of screening
- Loss of blood or blood products in excess of 450 mL within 60 days prior to screening
- Used any investigational drug within 60 days prior to screening
- Recent history of alcohol or drug abuse
- Any participant who currently uses or has used tobacco products or nicotine-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) for one month or more prior to screening
- Significant abnormalities in lumbar spine
- History of clinically significant back pain, back pathology, and/or back injury
- History of migraines, and/or frequent, severe headaches
- History or presence of significant active bleeding or coagulation disorder or use of non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
- Allergy to lidocaine (Xylocaine®) or related drugs
- History of adverse reaction to lumbar puncture or epidural procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL - Early Phase Clinical Unit-Los Angeles
Glendale, California, 91206
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TS-161 Administered Orally to Healthy Male and Female Participants
This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated.
The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single dose, cerebrospinal fluid [CSF] collection: Cohort 6), and Part C (multiple ascending dose: Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.
- Conditions
- Healthy Volunteers
- Being tested
- TS-161, TS-161 Placebo
- Keywords
- TS-161, CSF, first-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-161Drug
TS-161 capsules
TS-161 PlaceboDrug
TS-161 matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1: TS-161 15 mg | Experimental | Single dose of TS-161 15 mg or placebo in a fasted condition. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part A: Cohort 2: TS-161 50 mg | Experimental | Single dose of TS-161 50 mg or placebo which will be dosed first in a fasted condition, and then in a fed condition, with a washout period in between 2 dosing. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part A: Cohort 3: TS-161 100 mg | Experimental | Single dose of TS-161 100 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part A: Cohort 4: TS-161 200 mg | Experimental | Single dose of TS-161 200 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part A: Cohort 5: TS-161 400 mg | Experimental | Single dose of TS-161 400 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part B: Cohort 6: TS-161 TBD | Experimental | Single dose of TS-161 in a fasted condition. The dose level will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161 |
| Part C: Cohort 7: TS-161 TBD | Experimental | Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part C: Cohort 8: TS-161 TBD | Experimental | Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
| Part C: Cohort 9: TS-161 TBD | Experimental | Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. Receives: Drug: TS-161; Drug: TS-161 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events
Measured: Parts A and B: Day 1 to Day 8; Part C: Day 1 to Day 17
TS-161 Plasma Pharmacokinetic Profile - Cmax
Maximum plasma concentration
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - Tmax
Time to maximum plasma concentration
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - AUC(0-last)
Area under the plasma concentration versus time curve from time zero to last measurable concentration
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - AUC(0-tau)
Area under the plasma concentration versus time curve over a dosing interval
Measured: Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - T1/2
Apparent terminal elimination half-life
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - CL/F
Apparent clearance following oral administration
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Plasma Pharmacokinetic Profile - Vd,z/F
Apparent volume of distribution following oral administration
Measured: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
TS-161 Urine Pharmacokinetic Profile - Ae
Amount excreted in urine
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
TS-161 Urine Pharmacokinetic Profile - Fe%
Percent of dose excreted in urine
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
TS-161 Urine Pharmacokinetic Profile - CLr
Renal Clearance
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
Secondary outcomes (5)
TS-161 CSF Pharmacokinetic Profile - Cmax
Maximum CSF concentration
Measured: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - Tmax
Time to maximum CSF concentration
Measured: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - AUC(0-last)
Area under the CSF concentration versus time curve from time zero to last
Measured: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - T1/2
Apparent terminal elimination half-life
Measured: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
Changes from baseline in relative and absolute powers of the delta, theta, alpha, beta and gamma bands using quantitative electroencephalogram (qEEG) compared to placebo
Measured: Part A: predose and at multiple time points (up to 8 hours) postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start3 Jun 2019
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical R&D Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919409
- Sponsor's protocol ID
- TS161-US101
- Status last verified
- Feb 2020
- First submitted
- 15 Apr 2019
- Last updated
- 28 Feb 2020
- Results posted
- 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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TS-161 Administered Orally to Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT03919409
- Acronym / sponsor ID
- TS161-US101
- Conditions
- Healthy Volunteers
- Keywords
- TS-161, CSF, first-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 18 Apr 2019 (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 Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated.
The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single dose, cerebrospinal fluid [CSF] collection: Cohort 6), and Part C (multiple ascending dose: Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1: TS-161 15 mg | Experimental | Drug: TS-161, Drug: TS-161 PlaceboSingle dose of TS-161 15 mg or placebo in a fasted condition. |
| Part A: Cohort 2: TS-161 50 mg | Experimental | Drug: TS-161, Drug: TS-161 PlaceboSingle dose of TS-161 50 mg or placebo which will be dosed first in a fasted condition, and then in a fed condition, with a washout period in between 2 dosing. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. |
| Part A: Cohort 3: TS-161 100 mg | Experimental | Drug: TS-161, Drug: TS-161 PlaceboSingle dose of TS-161 100 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. |
| Part A: Cohort 4: TS-161 200 mg | Experimental | Drug: TS-161, Drug: TS-161 PlaceboSingle dose of TS-161 200 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. |
| Part A: Cohort 5: TS-161 400 mg | Experimental | Drug: TS-161, Drug: TS-161 PlaceboSingle dose of TS-161 400 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts. |
| Part B: Cohort 6: TS-161 TBD | Experimental | Drug: TS-161Single dose of TS-161 in a fasted condition. The dose level will be determined based on the results from the preceding cohorts. |
| Part C: Cohort 7: TS-161 TBD | Experimental | Drug: TS-161, Drug: TS-161 PlaceboDaily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. |
| Part C: Cohort 8: TS-161 TBD | Experimental | Drug: TS-161, Drug: TS-161 PlaceboDaily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. |
| Part C: Cohort 9: TS-161 TBD | Experimental | Drug: TS-161, Drug: TS-161 PlaceboDaily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male and female participants between 18 and 55 years of age, inclusive
- Body weight ≥ 45 kg
- Body Mass Index (BMI) 18 - 30 kg/m^2, inclusive
Key exclusion criteria (20 listed)
- Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
- History or presence of psychiatric or neurologic disease or condition
- History of seizures
- Abnormal EEG observed at screening
- Abnormal blood pressure
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 |
|---|---|---|
| TS-161TS-161 capsules | Drug | Part A: Cohort 1: TS-161 15 mg, Part A: Cohort 2: TS-161 50 mg, Part A: Cohort 3: TS-161 100 mg, Part A: Cohort 4: TS-161 200 mg, Part A: Cohort 5: TS-161 400 mg, Part B: Cohort 6: TS-161 TBD, Part C: Cohort 7: TS-161 TBD, Part C: Cohort 8: TS-161 TBD, Part C: Cohort 9: TS-161 TBD |
| TS-161 PlaceboTS-161 matching placebo capsules | Drug | Part A: Cohort 1: TS-161 15 mg, Part A: Cohort 2: TS-161 50 mg, Part A: Cohort 3: TS-161 100 mg, Part A: Cohort 4: TS-161 200 mg, Part A: Cohort 5: TS-161 400 mg, Part C: Cohort 7: TS-161 TBD, Part C: Cohort 8: TS-161 TBD, Part C: Cohort 9: TS-161 TBD |
Primary outcome
Incidence and severity of Adverse Events
Time frame: Parts A and B: Day 1 to Day 8; Part C: Day 1 to Day 17
TS-161 Plasma Pharmacokinetic Profile - Cmax
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Maximum plasma concentration
TS-161 Plasma Pharmacokinetic Profile - Tmax
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Time to maximum plasma concentration
TS-161 Plasma Pharmacokinetic Profile - AUC(0-last)
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose
Area under the plasma concentration versus time curve from time zero to last measurable concentration
TS-161 Plasma Pharmacokinetic Profile - AUC(0-tau)
Time frame: Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Area under the plasma concentration versus time curve over a dosing interval
TS-161 Plasma Pharmacokinetic Profile - T1/2
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Apparent terminal elimination half-life
TS-161 Plasma Pharmacokinetic Profile - CL/F
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Apparent clearance following oral administration
TS-161 Plasma Pharmacokinetic Profile - Vd,z/F
Time frame: Parts A and B: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part C: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 9 predose, Day 10 predose and at multiple time points (up to 48 hours) postdose
Apparent volume of distribution following oral administration
TS-161 Urine Pharmacokinetic Profile - Ae
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
Amount excreted in urine
TS-161 Urine Pharmacokinetic Profile - Fe%
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
Percent of dose excreted in urine
TS-161 Urine Pharmacokinetic Profile - CLr
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose; Part C: Day 1 predose and pooled for multiple intervals (up to 48 hours after last dose) postdose
Renal Clearance
5 secondary outcomes
TS-161 CSF Pharmacokinetic Profile - Cmax
Time frame: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - Tmax
Time frame: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - AUC(0-last)
Time frame: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
TS-161 CSF Pharmacokinetic Profile - T1/2
Time frame: Part B: Day 1 predose and at multiple time points (up to 24 hours) postdose
Changes from baseline in relative and absolute powers of the delta, theta, alpha, beta and gamma bands using quantitative electroencephalogram (qEEG) compared to placebo
Time frame: Part A: predose and at multiple time points (up to 8 hours) postdose
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 28 Feb 2020.
- 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.
Taisho Director study director
Taisho Pharmaceutical R&D Inc.
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 TS-161 in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. 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 3 inclusion and 20 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 28 Feb 2020. 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?
Incidence and severity of Adverse Events (time frame: Parts A and B: Day 1 to Day 8; Part C: Day 1 to Day 17). The study lists 11 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 28 Feb 2020.