Healthy VolunteersPhase 1NCT04831502
Bioavailability and Food Effect Study of Two Formulations of TAK-906
A Phase 1 study testing TAK-906 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. 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?
- TAK-906
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 2 Feb 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test.
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram per square meter (kg/m^2) at the screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee.
Who cannot join
- Presence of infectious diseases (example, Coronavirus disease-19 [COVID-19] and flu) at the time of screening or check-in.
- Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy).
- History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at screening or check-in.
- Positive urine cotinine at screening.
Show all 16Show fewer
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- QT interval corrected for heart rate using Frederica's equation (QTcF) is greater than (>) 450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
- Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.
- Unable to refrain from or anticipates the use of:
- o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 grams [g] per 24 hours) may be administered at the discretion of the investigator or designee; sponsor must be consulted prior to administering acetaminophen to a participants.
- Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 30 days prior to the first dosing and throughout the study.
- Is lactose intolerant or unable/unwilling to eat the high-fat, high-calorie breakfast.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dosing. The 30-day window or 5 half lives (whichever is longer) will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects
The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting.
This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.
Read the detailed description
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test [Treatment B]) relative to single oral dose of 50 mg capsule (reference [Treatment A]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B).
The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences.
This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-906
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-906Drug
TAK-906 Tablets.
TAK-906Drug
TAK-906 Capsules.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C) | Experimental | Participants will receive TAK-906 50 milligram (mg) as Treatment A (TAK-906 capsule) and Treatment B (TAK-906 tablet) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. Receives: Drug: TAK-906 |
| Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) | Experimental | Participants will receive TAK-906 50 mg as Treatment B (TAK-906 tablet) and Treatment A (TAK-906 capsule) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. Receives: Drug: TAK-906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Secondary outcomes (15)
Number of Participants Reporting one or More Adverse Events (AEs)
Measured: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Measured: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC%extrap: Percent of AUCinf Extrapolated After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tmax: Time to Reach Maximum Plasma Concentration After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tlag: Lag Time to First Quantifiable Concentration After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Kel: Apparent Terminal First Order Elimination Rate Constant After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
CL/F: Apparent Plasma Clearance After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
t½: Terminal Half-life After Single Dose of TAK-906
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start2 Apr 2021
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Why it stopped: Business decision
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.
- More trials run by TakedaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831502
- Sponsor's protocol ID
- TAK-906-1005
- Status last verified
- Mar 2022
- First submitted
- 1 Apr 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04831502
- Acronym / sponsor ID
- TAK-906-1005
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 5 Apr 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.
The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting.
This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.
Detailed description
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test [Treatment B]) relative to single oral dose of 50 mg capsule (reference [Treatment A]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B).
The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences.
This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C) | Experimental | Drug: TAK-906Participants will receive TAK-906 50 milligram (mg) as Treatment A (TAK-906 capsule) and Treatment B (TAK-906 tablet) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. |
| Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) | Experimental | Drug: TAK-906Participants will receive TAK-906 50 mg as Treatment B (TAK-906 tablet) and Treatment A (TAK-906 capsule) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test.
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram per square meter (kg/m^2) at the screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee.
Key exclusion criteria (16 listed)
- Presence of infectious diseases (example, Coronavirus disease-19 [COVID-19] and flu) at the time of screening or check-in.
- Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy).
- History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at screening or check-in.
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 |
|---|---|---|
| TAK-906TAK-906 Tablets. | Drug | Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C), Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) |
| TAK-906TAK-906 Capsules. | Drug | Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C), Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) |
Primary outcome
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
15 secondary outcomes
Number of Participants Reporting one or More Adverse Events (AEs)
Time frame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC%extrap: Percent of AUCinf Extrapolated After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tmax: Time to Reach Maximum Plasma Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tlag: Lag Time to First Quantifiable Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Kel: Apparent Terminal First Order Elimination Rate Constant After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
CL/F: Apparent Plasma Clearance After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
t½: Terminal Half-life After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
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 24 Mar 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Study Director study director
Takeda
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 TAK-906 in people with Healthy Volunteers, run by Takeda 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 16 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 24 Mar 2022. 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 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?
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose). 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 24 Mar 2022.