Heathy VolunteerPhase 1NCT03363815
A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
A Phase 1 study testing CC-90001, Omeprazole and Midazolam in people with Heathy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathy Volunteer
- What is being tested?
- CC-90001, Omeprazole and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 29 Jul 2018
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy all of the following criteria to be eligible for enrollment into the study:
- Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
- Must be able to communicate with the investigator and to understand and adhere to the study visit schedule and other protocol requirements.
- Must be a male or female of any race, aged ≥ 18 to ≤ 64 years of age (inclusive) at the time of signing the ICF.
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing during the course of the study and at the end of the study. This applies even if the subject practices true abstinence from heterosexual contact. Note: Females of childbearing potential are not permitted in Part 4.
- Part 4 only: Female subjects must be of nonchildbearing potential as confirmed by medical history. Females of childbearing potential are permitted in Parts 1, 2, and 3.
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- Male subjects must practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis, as applicable) or agree to use a male condom (latex or nonlatex condom not made out of natural [animal] membrane [eg, polyurethane]) during sexual contact with a pregnant female or a FCBP while participating in the study and for at least 28 days after the last dose of study drug, even if he has undergone a successful vasectomy as confirmed by medical history.
- Must have a body mass index ≥ 18 and ≤ 33 kg/m2 (inclusive) at the time of signing the ICF.
- Must be healthy as determined by the investigator on the basis of medical history, clinical laboratory test results, vital signs, and 12-lead ECG at screening and Period 1 check-in, as applicable:
- Must be afebrile (febrile is defined as ≥ 38°C or 100.3°F).
- Systolic blood pressure must be in the range of 90 to 140 mmHg, diastolic blood pressure must be in the range of 55 to 90 mmHg, and pulse rate must be in the range of 50 to 110 bpm. Repeat vital signs may be measured at investigator discretion.
- Corrected QT interval using Fridericia's formula (QTcF) value must be ≤ 430 msec for male subjects and ≤ 450 msec for female subjects. An ECG may be repeated up to two times, and the average of the QTcF values will be used to determine subject eligibility.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment into the study:
- History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders as determined by the investigator.
- Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable).
- Use of any prescribed systemic or topical medication, including vaccines, within 30 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 14 days of the first dose administration.
- Use of any metabolic enzyme inhibitors or inducers that would affect the relevant drugs for that part of the study within 30 days of the first dose administration unless determined by the investigator that there will be no impact on the study integrity or subject safety. The Indiana University "P450 Drug Interaction Table" should be used to determine inhibitors and/or inducers of metabolic enzymes (http://medicine.iupui.edu/clinpharm/ddis/table/aspx).
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- Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure). Appendectomy and cholecystectomy are acceptable.
- Donated blood or plasma within 8 weeks before the first dose administration.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before dosing or positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing or positive alcohol screen.
- Known to have serum hepatitis; known to be a carrier of the hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody (anti-HBc), or hepatitis C antibody (HCV Ab); have a positive result to the test for hepatitis B or hepatitis C virus at screening or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening. Subjects whose results are compatible with prior immunization against hepatitis B may be included at the discretion of the investigator.
- Use of tobacco- or nicotine-containing products within 3 months prior to Period 1 check in.
- History of multiple drug allergies (ie, 2 or more).
- Are allergic to or hypersensitive to any of the drugs used in the part of the study in which the subject will participate.
- Has any medical condition, medical history, or concomitant medication that is contraindicated in the applicable drug labeling.
- Female subject who is pregnant or breastfeeding. Part 4 only: Female of childbearing potential.
- Additional criteria for Part 1 only:
- History of any significant head trauma as determined by the investigator.
- History of major surgery within 3 months of screening or planned surgery within 14 days of the last dose of study drug.
- Any clinically significant current evidence, personal history, or family history of disorder of hemostasis, congenital or acquired bleeding tendency, or thrombocytopenia.
- History of hemorrhagic diathesis, bleeding complication after surgical procedure or trauma, nose or gingival bleeding, gastrointestinal ulcers with hemorrhage, or menorrhagia (females only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Four-part, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows:
- Screening (Days -21 through -2)
- Baseline phase for each study period (Periods 1 and 2)
- Treatment phase for each study period (Periods 1 and 2)
- Follow-up telephone call
Read the detailed description
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only.
Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2.
In Part 1, Single doses of omeprazole, midazolam, warfarin, and vitamin K will be administered under fasted conditions on Period 1, Day 1. During Period 2, subjects will receive once daily (QD) doses of CC-90001 from Days 1 through 18. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC-90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered single doses of omeprazole, midazolam, warfarin, and vitamin K under fasted conditions.
In Part 2, A single dose of rosuvastatin will be administered under fasted conditions on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drug, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered a single dose of rosuvastatin under fasted conditions.
In Part 3, single doses of metformin and digoxin will be administered under fasted conditions on Period 1, Day 1.
There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered single doses of metformin and digoxin under fasted conditions.
In Part 4, a single dose of nintedanib will be administered 30 minutes after the start of a standard breakfast on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 14. On the day of dosing with probe drug, CC 90001 will be dosed 30 minutes after the start of a standard breakfast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered a single dose of nintedanib 30 minutes after the start of a standard breakfast.
- Conditions
- Heathy Volunteer
- Being tested
- CC-90001, Omeprazole, Midazolam, Warfarin, Vitamin K
- Keywords
- Healthy Volunteer, CC-90001, Pharmacokinetics, Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, Nintedanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90001Drug
CC-90001
OmeprazoleDrug
Omeprazole
MidazolamDrug
Midazolam
WarfarinDrug
Warfarin
Vitamin KDietary supplement
Vitamin K
RosuvastatinDrug
Rosuvastatin
MetforminDrug
Metformin
DigoxinDrug
Digoxin
NintedanibDrug
Nintedanib
| Study group | Role | What they receive |
|---|---|---|
| Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 | Experimental | Patient will receive CC-90001, 20mg Omeprazole, 2mg Midazolam 10mg Warfarin and 10mg Vitamin K Receives: Drug: CC-90001; Drug: Omeprazole; Drug: Midazolam; Drug: Warfarin; Dietary Supplement: Vitamin K |
| Part 2- Rosuvastatin and CC-90001 | Experimental | Patients will receive CC-90001 and 10mg of Rosuvastatin Receives: Drug: CC-90001; Drug: Rosuvastatin |
| Part 3: Metformin + Digoxin and CC-90001 | Experimental | Patients will receive CC-90001, 500mg Metformin and 0.25mg, Digoxin Receives: Drug: CC-90001; Drug: Metformin; Drug: Digoxin |
| Part 4: Nintedanib and CC-90001 | Experimental | Patients will receive CC-90001 and 100mg of Nintedanib Receives: Drug: CC-90001; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic- Cmax
Maximum observed plasma concentration
Measured: up to approximately 2.5 months
Pharmacokinetic- AUC0-t
AUC from time zero to the last quantifiable concentration
Measured: up to approximately 2.5 months
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse events
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start4 Dec 2017
- Primary completion29 Jul 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy VolunteerStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Ramirez-Valle, MD, PhD., Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363815
- Sponsor's protocol ID
- CC-90001-CP-004
- Other IDs
- U1111-1205-5329
- Status last verified
- Jan 2019
- First submitted
- 1 Dec 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Four-part, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03363815
- Acronym / sponsor ID
- CC-90001-CP-004
- Conditions
- Heathy Volunteer
- Keywords
- Healthy Volunteer, CC-90001, Pharmacokinetics, Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 6 Dec 2017 (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 four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows:
- Screening (Days -21 through -2)
- Baseline phase for each study period (Periods 1 and 2)
- Treatment phase for each study period (Periods 1 and 2)
- Follow-up telephone call
Detailed description
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only.
Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2.
In Part 1, Single doses of omeprazole, midazolam, warfarin, and vitamin K will be administered under fasted conditions on Period 1, Day 1. During Period 2, subjects will receive once daily (QD) doses of CC-90001 from Days 1 through 18. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC-90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered single doses of omeprazole, midazolam, warfarin, and vitamin K under fasted conditions.
In Part 2, A single dose of rosuvastatin will be administered under fasted conditions on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drug, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered a single dose of rosuvastatin under fasted conditions.
In Part 3, single doses of metformin and digoxin will be administered under fasted conditions on Period 1, Day 1.
There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered single doses of metformin and digoxin under fasted conditions.
In Part 4, a single dose of nintedanib will be administered 30 minutes after the start of a standard breakfast on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 14. On the day of dosing with probe drug, CC 90001 will be dosed 30 minutes after the start of a standard breakfast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered a single dose of nintedanib 30 minutes after the start of a standard breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 | Experimental | Drug: CC-90001, Drug: Omeprazole, Drug: Midazolam, Drug: Warfarin, Dietary Supplement: Vitamin KPatient will receive CC-90001, 20mg Omeprazole, 2mg Midazolam 10mg Warfarin and 10mg Vitamin K |
| Part 2- Rosuvastatin and CC-90001 | Experimental | Drug: CC-90001, Drug: RosuvastatinPatients will receive CC-90001 and 10mg of Rosuvastatin |
| Part 3: Metformin + Digoxin and CC-90001 | Experimental | Drug: CC-90001, Drug: Metformin, Drug: DigoxinPatients will receive CC-90001, 500mg Metformin and 0.25mg, Digoxin |
| Part 4: Nintedanib and CC-90001 | Experimental | Drug: CC-90001, Drug: NintedanibPatients will receive CC-90001 and 100mg of Nintedanib |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects must satisfy all of the following criteria to be eligible for enrollment into the study:
- Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
- Must be able to communicate with the investigator and to understand and adhere to the study visit schedule and other protocol requirements.
- Must be a male or female of any race, aged ≥ 18 to ≤ 64 years of age (inclusive) at the time of signing the ICF.
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing during the course of the study and at the end of the study. This applies even if the subject practices true abstinence from heterosexual contact. Note: Females of childbearing potential are not permitted in Part 4.
Key exclusion criteria (22 listed)
- The presence of any of the following will exclude a subject from enrollment into the study:
- History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders as determined by the investigator.
- Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable).
- Use of any prescribed systemic or topical medication, including vaccines, within 30 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 14 days of the first dose administration.
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 |
|---|---|---|
| CC-90001CC-90001 | Drug | Part 2- Rosuvastatin and CC-90001, Part 3: Metformin + Digoxin and CC-90001, Part 4: Nintedanib and CC-90001, Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 |
| OmeprazoleOmeprazole | Drug | Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 |
| MidazolamMidazolam | Drug | Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 |
| WarfarinWarfarin | Drug | Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 |
| Vitamin KVitamin K | Dietary supplement | Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 |
| RosuvastatinRosuvastatin | Drug | Part 2- Rosuvastatin and CC-90001 |
| MetforminMetformin | Drug | Part 3: Metformin + Digoxin and CC-90001 |
| DigoxinDigoxin | Drug | Part 3: Metformin + Digoxin and CC-90001 |
| NintedanibNintedanib | Drug | Part 4: Nintedanib and CC-90001 |
Primary outcome
Pharmacokinetic- Cmax
Time frame: up to approximately 2.5 months
Maximum observed plasma concentration
Pharmacokinetic- AUC0-t
Time frame: up to approximately 2.5 months
AUC from time zero to the last quantifiable concentration
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
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 25 Jan 2019.
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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.
Francisco Ramirez-Valle, MD, PhD. study director
Celgene
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 CC-90001, Omeprazole and Midazolam in people with Heathy Volunteer, run by Celgene 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 12 inclusion and 22 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 25 Jan 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 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?
Pharmacokinetic- Cmax (time frame: up to approximately 2.5 months). The study lists 2 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 25 Jan 2019.