SchizophreniaPhase 1NCT01289080
Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects
A Phase 1 study testing OPC-34712 in people with Schizophrenia and Psychiatric Disorders, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
Trial summary
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychiatric Disorders
- What is being tested?
- OPC-34712
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female (non-childbearing potential) subjects ≥ 18 years of age.
- Ability to provide written informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
- Male and female subjects who are surgically sterile; female subjects who have been postmenopausal for at least 12 consecutive months (confirmed by follicle stimulating hormone sample at Screening); or male subjects who agree to remain abstinent or to practice double-barrier forms of birth control and refrain from sperm donation from trial Screening through 90 days from the last dose of the investigational medicinal product.
- Body weight within ± 35% of ideal body weight as defined in the 1983 Metropolitan Height and Weight Tables (see Appendix 4, Appendix 5, and Appendix 6). Minimum body weight no less than 50 kg.
- Subjects who are in good health as determined by a medical history, physical examination, serum chemistry, hematology, urinalysis, hepatitis B and C tests, and human immunodeficiency virus (HIV) testing.
- Creatinine clearance > 80 mL/min indicating normal renal function.
Show all 9Show fewer
- Renally impaired subjects may be taking medications which, in the opinion of the clinical investigator and sponsor, are believed to be therapeutic for the subjects (but do not affect OPC-34712 absorption, distribution, metabolism, or elimination). Inhibitors and inducers of CYP3A4 and inhibitors of CYP2D6 are not allowed.
- Creatinine clearance < 30 mL/min indicating severe renal impairment.
- Subjects with renal impairment should have relatively stable renal function as determined by creatinine clearance and otherwise be in generally good health.
Who cannot join
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk.
- History of drug and/or alcohol abuse within 2 years prior to Screening.
- A positive urine alcohol test and/or urine drug screen for substance of abuse at Screening or upon check-in to the trial site.
- The donation of blood or plasma within 30 days prior to dosing.
- Any history of significant bleeding or hemorrhagic tendencies.
Show all 29Show fewer
- History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV).
- History of acquired immunodeficiency syndrome or determined human immunodeficiency virus (HIV) positive at Screening.
- Use of an investigational drug or product, or participation in a drug trial within 30 days prior to dosing.
- Previous exposure to OPC-34712.
- History of clinically significant drug allergies or sensitivities.
- Subjects who are pregnant or breastfeeding. A negative serum pregnancy test must be confirmed prior to administration of trial medication for all female subjects.
- Subjects who have a supine pulse rate, after resting for ≥ 3 minutes, outside the range of 40 to 90 bpm. The sponsor may allow exceptions if they are not deemed clinically significant.
- Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at Screening or Day -1.
- Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to dosing and antibiotics within 30 days prior to dosing. The sponsor may allow exceptions only if the medication's administration is deemed unlikely to impact the pharmacokinetic result. Inhibitors and inducers of CYP3A4 and inhibitors of CYP2D6 are not allowed.
- Subjects who have supine, sitting, or standing blood pressure, after resting for ≥ 3 minutes, higher than 130/80 mmHg or lower than 100/50 mmHg. The sponsor may allow exceptions if they are not deemed clinically significant.
- Subjects that have undergone a renal transplant.
- Renally impaired subjects may be taking medications which, in the opinion of the clinical investigator and sponsor, are believed to be therapeutic for the subjects (but do not affect OPC-34712 absorption, distribution, metabolism, or elimination). Inhibitors and inducers of CYP3A4 and inhibitors of CYP2D6 are not allowed.
- Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at Screening or Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.
- Subject requiring dialysis or expected to require dialysis within 45 days.
- Subjects who have supine, sitting, or standing blood pressure, after resting for ≥ 3 minutes, higher than 160/95 mmHg or lower than 100/50 mmHg. The sponsor may allow exceptions if they are not deemed clinically significant.
- Subjects with evidence of delirium.
- Clinically relevant changes on electrocardiogram such as any atrioventricular block, prolongation of the QRS complex over 120 msec (for both male and female subjects), or with a QTcF interval ≥ 450 msec.
- Any subject who, in the opinion of the sponsor or the investigator, should not participate in the trial.
- Consumption of alcohol and/or food and beverages containing methylxanthines, grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 72 hours prior to dosing.
- Use of any drug known or suspected of inhibiting or stimulating hepatic drug metabolism enzymes within 30 days prior to Screening.
- Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to Screening through the end of the trial (eg, occupational exposure to pesticides, organic solvents).
- History of serious mental disorders.
- Major surgery of the digestive tract (excluding appendectomy).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Otsuka Investigational Site
Miami, Florida, 33014
Otsuka Investigational Site
Minneapolis, Minnesota, 55404
About this study
Official title: A Single-dose, Open-label, Parallel-group, Matched Trial Evaluating the Pharmacokinetics of Oral OPC-34712 Tablets in Subjects With Normal Renal Function and Renally Impaired Subjects
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.
- Conditions
- Schizophrenia, Psychiatric Disorders
- Being tested
- OPC-34712
- Keywords
- Schizophrenia, psychiatric disorders, renal failure
- Medical subject headings
- Schizophrenia, Mental Disorders, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-34712Drug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | subjects with normal renal function Receives: Drug: OPC-34712 |
| Group 2 | Active comparator | severely renally impaired subjects Receives: Drug: OPC-34712 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).
Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Secondary outcomes (11)
AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUCt was estimated using the linear trapezoidal rule.
Measured: Day 1 to Day 8
AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUC∞ was estimated using the linear trapezoidal rule.
Measured: Day 1 to Day 8
Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.
Measured: Day 1 to Day 8
Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).
The value of CL/F was determined as Dose/AUC∞. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood.
Measured: Day 1 to Day 8
Unbound Fraction of Brexpiprazole in Plasma (fu).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).
Urine samples were collected at Predose at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).
Urine samples were collected at Predose and at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Measured: Day 1 to Day 8
The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.
An adverse event (AE) was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
Measured: AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aleksandar Skuban, Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289080
- Sponsor's protocol ID
- 331-09-226
- Status last verified
- Sep 2015
- First submitted
- 1 Feb 2011
- Last updated
- 29 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Parallel-group, Matched Trial Evaluating the Pharmacokinetics of Oral OPC-34712 Tablets in Subjects With Normal Renal Function and Renally Impaired Subjects
- ClinicalTrials.gov ID
- NCT01289080
- Acronym / sponsor ID
- 331-09-226
- Conditions
- Schizophrenia, Psychiatric Disorders
- Keywords
- Schizophrenia, psychiatric disorders, renal failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 29 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: OPC-34712subjects with normal renal function |
| Group 2 | Active comparator | Drug: OPC-34712severely renally impaired subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female (non-childbearing potential) subjects ≥ 18 years of age.
- Ability to provide written informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
- Male and female subjects who are surgically sterile; female subjects who have been postmenopausal for at least 12 consecutive months (confirmed by follicle stimulating hormone sample at Screening); or male subjects who agree to remain abstinent or to practice double-barrier forms of birth control and refrain from sperm donation from trial Screening through 90 days from the last dose of the investigational medicinal product.
- Body weight within ± 35% of ideal body weight as defined in the 1983 Metropolitan Height and Weight Tables (see Appendix 4, Appendix 5, and Appendix 6). Minimum body weight no less than 50 kg.
- Subjects who are in good health as determined by a medical history, physical examination, serum chemistry, hematology, urinalysis, hepatitis B and C tests, and human immunodeficiency virus (HIV) testing.
Key exclusion criteria (29 listed)
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk.
- History of drug and/or alcohol abuse within 2 years prior to Screening.
- A positive urine alcohol test and/or urine drug screen for substance of abuse at Screening or upon check-in to the trial site.
- The donation of blood or plasma within 30 days prior to dosing.
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 |
|---|---|---|
| OPC-34712administered orally | Drug | Group 1, Group 2 |
Primary outcome
Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).
Time frame: Day 1 to Day 8
Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).
Time frame: Day 1 to Day 8
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).
Time frame: Day 1 to Day 8
Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
11 secondary outcomes
AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).
Time frame: Day 1 to Day 8
AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).
Time frame: Day 1 to Day 8
Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).
Time frame: Day 1 to Day 8
Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).
Time frame: Day 1 to Day 8
Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).
Time frame: Day 1 to Day 8
Unbound Fraction of Brexpiprazole in Plasma (fu).
Time frame: Day 1 to Day 8
Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).
Time frame: Day 1 to Day 8
Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).
Time frame: Day 1 to Day 8
Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).
Time frame: Day 1 to Day 8
Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).
Time frame: Day 1 to Day 8
The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.
Time frame: AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Aleksandar Skuban study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC-34712 in people with Schizophrenia and Psychiatric Disorders, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites 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 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 29 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u). (time frame: Day 1 to Day 8). 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 29 Oct 2015.