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HealthyPhase 1NCT03812198

A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People

A Phase 1 study testing LEO 32731 modified release tablet, LEO 32731 blend, hard capsule and LEO 32731 API, hard capsule in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4 different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in 3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will participate in 3 treatment periods. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LEO 32731 modified release tablet, LEO 32731 blend, hard capsule and LEO 32731 API, hard capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
22 Jan 2019to 13 Jun 2019
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

  • Age 18 to 65 years, inclusive.
  • Body mass index of 18.5 to 29.9 kg/m2, inclusive.
  • In good health, at the discretion of the investigator, as determined by: medical history, physical examination, vital sign assessment (specifically, blood pressure must be within normal reference range), 12-lead ECG, clinical laboratory evaluations, aspartate aminotransferase and alanine aminotransferase not above the upper limit of normal (Gilbert's syndrome is not acceptable).
  • Female subjects of childbearing potential must be willing to use a highly effective form of birth control in conjunction with a barrier method of contraception throughout the trial and for at least 90 days after final follow-up.
  • Male subjects with a female partner of childbearing potential must be willing to use a highly effective form of birth control in conjunction with male barrier method of contraception (i.e. male condom with spermicide) throughout the trial and for at least 90 days after final follow-up.

Who cannot join

  • Systemic or topical treatment within 14 days prior to first dose administration unless in the opinion of the investigator the medication will not interfere with the trial procedures or compromise safety.
  • Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to first dose administration.
  • Subjects who smoke more than an average of 10 cigarettes per day.
  • History of chronic alcohol or drug abuse within 12 months prior to screening.
  • Subjects with ≥3 bowel movements per day.
  • Any disorder which is not stable and could: Affect the safety of the subject throughout the trial; Influence the findings of the trial; Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, GI, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders and major physical impairment.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • LEO Pharma Investigational Site

    Leeds

Other trials in United Kingdom

About this study

Official title: A Phase 1, 3-part, Single (Open-label) and Multiple (Double-blind, Placebo-controlled) Oral Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of LEO 32731 Formulations in Healthy Subjects

This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4 different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in 3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will participate in 3 treatment periods.

Read the detailed description

Part 1 will evaluate the pharmacokinetics of single doses of 4 test formulations of LEO 32731 compared with a reference formulation. Part 2 will evaluate the effect of food on the pharmacokinetics of selected test formulations of LEO 32731. Part 3 will evaluate the tolerability and safety of selected test formulations of LEO 32731 after multiple dosing.

Based on data from Part 1, up to 3 formulations will be taken forward to Part 2. If none of the formulations are considered appropriate to take forward to Part 2, the trial will stop after Part 1. Similarly, based on data from Part 2, up to 2 formulations will be taken forward to Part 3. If none of the formulations are considered appropriate to take forward to Part 3, the trial will stop after Part 2.

Conditions
Healthy
Being tested
LEO 32731 modified release tablet, LEO 32731 blend, hard capsule, LEO 32731 API, hard capsule, LEO 32731 soft capsule, LEO 32731 gastro-resistant capsule
Keywords
healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEO 32731 modified release tabletDrug

    At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.

  • LEO 32731 blend, hard capsuleDrug

    At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.

  • LEO 32731 API, hard capsuleDrug

    At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.

  • LEO 32731 soft capsuleDrug

    At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.

  • LEO 32731 gastro-resistant capsuleDrug

    At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.

  • LEO 32731Drug

    At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.

  • PlaceboOther

    At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.

Study groups in NCT03812198
Study groupRoleWhat they receive
Group 1-1Active comparatorPart 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 modified release tablet; LEO 32731 blend, hard capsule; LEO 32731 API hard capsule (reference formulation).
Receives: Drug: LEO 32731 modified release tablet; Drug: LEO 32731 blend, hard capsule; Drug: LEO 32731 API, hard capsule
Group 1-2Active comparatorPart 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 soft capsule; LEO 32731 gastro-resistant capsule; LEO 32731 API hard capsule (reference formulation).
Receives: Drug: LEO 32731 API, hard capsule; Drug: LEO 32731 soft capsule; Drug: LEO 32731 gastro-resistant capsule
Group 2-1ExperimentalPart 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast. The formulation depends on the outcome of Part 1.
Receives: Drug: LEO 32731
Group 2-2ExperimentalPart 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast. The formulation depends on the outcome of Part 1.
Receives: Drug: LEO 32731
Group 2-3ExperimentalPart 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast. The formulation depends on the outcome of Part 1.
Receives: Drug: LEO 32731
Group 3-1Placebo comparatorSubjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.
Receives: Drug: LEO 32731; Other: Placebo
Group 3-2Placebo comparatorSubjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.
Receives: Drug: LEO 32731; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1. AUC0-∞

    AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  2. Part 1. Relative bioavailability (F-rel)

    F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  3. Part 1. C-max

    C-max: Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  4. Part 1. t-max

    t-max: Time to reach maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  5. Part 2. AUC0-∞

    AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  6. Part 2. Relative bioavailability (F-rel)

    F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  7. Part 2. C-max

    C-max: Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  8. Part 2. t-max

    t-max: Time to reach maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  9. Part 3. Number of GI-related AEs and number of subjects with GI-related AEs during the treatment period

    AEs: adverse events; GI: gastrointestinal

    Measured: From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3

Secondary outcomes (35)

  1. Part 1. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.

    AEs: adverse events; GI: gastrointestinal

    Measured: 24 days (from first dose in first treatment period until end of last treatment period) in Part 1

  2. Part 1. Number of total AEs and number of subjects with AEs during each combination of treatment and period

    AEs: adverse events

    Measured: 24 days (from first dose in first treatment period until end of last treatment period) in Part 1

  3. Part 1. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose

  4. Part 1. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose

  5. Part 1. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose

  6. Part 1. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose

  7. Part 1. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1

  8. Part 1. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1

  9. Part 1. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1

  10. Part 1. AUC0-t

    AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  11. Part 1. t1/2

    t1/2: apparent terminal half-life

    Measured: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1

  12. Part 2. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.

    AEs: adverse events; GI: gastrointestinal

    Measured: 28 days (from first dose in first treatment period until end of last treatment period) in Part 2

  13. Part 2. Number of total AEs and number of subjects with AEs during each combination of treatment and period

    AEs: adverse events

    Measured: 28 days (from first dose in first treatment period until end of last treatment period) in Part 2

  14. Part 2. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose

  15. Part 2. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose

  16. Part 2. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose

  17. Part 2. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose

  18. Part 2. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2

  19. Part 2. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2

  20. Part 2. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2

  21. Part 2. AUC0-t

    AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  22. Part 2. t1/2

    t1/2: apparent terminal half-life

    Measured: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2

  23. Part 3. AUC0-∞

    AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3

  24. Part 3. C-max

    C-max: Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3

  25. Part 3. t-max

    t-max: Time to reach maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3

  26. Part 3. AUC0-t

    AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration

    Measured: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3

  27. Part 3. t1/2

    t1/2: apparent terminal half-life

    Measured: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3

  28. Part 3. Number of total AEs and number of subjects with AEs during the treatment period

    AEs: adverse events

    Measured: From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3

  29. Part 3. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)

  30. Part 3. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)

  31. Part 3. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)

  32. Part 3. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)

  33. Part 3. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)

  34. Part 3. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)

  35. Part 3. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'

    QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator

    Measured: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start22 Jan 2019
  3. Primary completion13 Jun 2019
  4. Study completion13 Jun 2019

Resources

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
Sequential
Model description
Part 1 (single dose, cross-over) Part 2 (single dose, cross-over with food effect evaluation) Part 3 (multiple dose, parallel)
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812198
Sponsor's protocol ID
LP0058-1442
Other IDs
2018-003282-34, 2018
Status last verified
Jun 2019
First submitted
18 Jan 2019
Last updated
1 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LEO 32731 modified release tablet, LEO 32731 blend, hard capsule and LEO 32731 API, hard capsule in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.

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 6 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 1 Jul 2019. 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 Kingdom. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1. AUC0-∞ (time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03812198.

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 2019.

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