Diabetes Mellitus, Type 2Phase 1NCT00625859
A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects
A Phase 1 study testing GSK189075 and Bupropion in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK189075 and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2008to 10 Apr 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 55 years inclusive.
- Body Mass Index (BMI) is between 19-35kg/m2 (inclusive), with a minimum body weight of 45kg.
- Subject must read and write at a comprehension level that is sufficient to provide written informed consent, and be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Subject has provided informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to the initiation of any study procedures.
Who cannot join
- General
- Presence of any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or 12-lead ECG, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. These include any unstable medical disorder; disorders that would interfere with the action, absorption, distribution, metabolism, or excretion of bupropion or GSK189075; disorders which may pose a safety concern or interfere with the accurate assessment of safety or efficacy.
- Laboratory
- Clinically significant abnormalities at Screening including:
- Systolic blood pressure outside the range of 90 - 140 mmHg, diastolic blood pressure outside the range of 50 - 90 mmHg, and pulse rate at rest > 100 and < 45 bpm.
- Positive tests for hepatitis B surface antigen, hepatitis C antibodies, and HIV.
Show all 56Show fewer
- Positive cotinine, drug and/or alcohol test.
- Significant ECG abnormalities are defined as follows:
- Parameter Range
- Heart Rate < 40 and >100 bpm
- PR Interval <120 and > 220 ms
- QRS duration < 70 and >120 ms
- QTC Interval (Bazett) > 450 ms
- ALT, alkaline phosphatase, or total bilirubin ³ 1.5 times the upper limits of normal (Note: Subjects with an increased total bilirubin may enter the study only if direct bilirubin is within normal limits).
- Fasting triglycerides >400 mg/dL (>11.3 mmol/L).
- Clinically significant abnormalities of T3 and TSH.
- Serum creatinine clearance <60ml/min (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
- A validated web-based calculator is found at:
- http://nephron.com/cgi-bin/MDRDSIdefault.cgi
- To calculate estimated GFR (mL/min/1.73m2) manually:
- = 186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American)
- = exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American))
- Any other clinically significant laboratory abnormality as determined by the Principal Investigator in consultation with the GSK Medical Monitor.
- Central Nervous System
- Current diagnosis or a previous history of mania, psychosis, major depression, or other major psychiatric disorder.
- Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure; those treated with other medications or treatment regimes that lower seizure threshold; those undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines or benzodiazepine-like agents).
- Note: A single childhood febrile seizure is not exclusionary.
- History or current diagnosis of anorexia nervosa or bulimia.
- Subjects who, in the investigator's judgement, pose a homicidal or suicidal risk, have ever made a suicide attempt, or have ever been homicidal.
- Hepatic and Gastrointestinal systems
- History of hepatic disease or known hepatic or biliary abnormalities, (with the exception of previously documented diagnosis of Gilbert's syndrome) and/or a history of biliary or gastrointestinal disorder, which might affect absorption, distribution, metabolism, or excretion of drugs (except appendectomy or cholecystectomy more than 12 weeks prior to the study).
- Endocrine system
- Untreated or unstable thyroid disease. Subjects taking thyroid medications must be on a stable dosing regimen for at least 4 weeks prior to the first dose of study drug until completion of the Follow-up visit.
- Cardiac system
- Subject has a history of clinically significant cardiac rhythm disorder or QTc interval ³450 milliseconds at Screening.
- Subject has history of ischemic heart disease, including stable/unstable angina or acute myocardial infarction.
- Uncontrolled hypertension with systolic blood pressure >140mm Hg and diastolic blood pressure >90mm Hg.
- Drugs and Alcohol
- Subject has a history of alcohol abuse or an average weekly intake of greater than 21 units per week (one unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer).
- Unwilling or unable to abstain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- Use of tobacco in any form (smoking cigarettes, cigars, and/or pipes, or chewing tobacco-containing products), for 4 weeks prior to Screening until completion of the Follow-up visit.
- Unwilling or unable to abstain from the use of prescription or non-prescription drugs, vitamins, or dietary/herbal supplements within 1 week prior to the first dose of study drug until completion of the Follow-up visit.
- Subject is currently using medications that may alter gastric/small bowel motility, result in diarrhea, or bind concomitant medications. For example, but not limited to: erythromycin, antacids, prokinetic agents and cholestyramine.
- Subject has a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation in this study.
- Concomitant medications usage that includes:
- Use of agents that are known to inhibit or induce cytochrome P450 enzymes within 14 days prior to the first dose of study medication , including grapefruit-containing products and St. John's Wort.
- Use of bupropion hydrochloride or GSK189075 within the last 6 months prior to Screening.
- Use of anti-depressant medication for clinically significant depression.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose in Treatment Period 1, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Note: Occasional use of acetaminophen and ibuprofen according to directions provided in the product label may be acceptable during the study, at the discretion of the Principal Investigator. Acetaminophen will be limited to doses up to 2 grams/day and ibuprofen at doses up to 1.2 grams/day.
- Drug hypersensitivity
- History of hypersensitivity to WELLBUTRIN SR, ZYBAN, GSK189075 or any of their constituents or closely related compounds.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Other
- Past treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days, or 5 half-lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3. (The washout period of 30 days is counted from the last dose of study drug in the previous study until the first dose of study drug).
- Participation in the study would result in subject's donation of blood in excess of 500mL within a 56-day period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, 6-sequence, 3-period, Crossover Drug Drug Interaction Study to Evaluate the Pharmacokinetics of Wellbutrin SR and GSK189075 When Co-administered or Administered Alone in Healthy Male Volunteers
The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. The results will help to determine if doses of GSK189075 and WELLBUTRIN SR can be safely taken together.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK189075, Bupropion, Placebo
- Keywords
- pharmacodynamics, Healthy adult male volunteers,, pharmacokinetics,
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK189075Drug
GSK189075 will be available as film-coated tablets with a dose of 250 milligrams.
BupropionDrug
Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally.
PlaceboDrug
Placebo tablets will be given to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence 1 | Experimental | Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
| Subjects receiving treatment sequence 2 | Experimental | Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
| Subjects receiving treatment sequence 3 | Experimental | Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
| Subjects receiving treatment sequence 4 | Experimental | Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
| Subjects receiving treatment sequence 5 | Experimental | Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
| Subjects receiving treatment sequence 6 | Experimental | Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Receives: Drug: GSK189075; Drug: Bupropion; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples and urine samples
Measured: on Day 14
Secondary outcomes (8)
adverse events, heart rate & blood pressure: each visit ecg: screening, days -1, 1, 4, 7, 13, 14, followup lab tests: screening, days -1, 4, 7, 13, 14, followup
Measured: Up to Week 12
GSK189074 Cmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
Measured: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Bupropion and GSK189074 tmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
Measured: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Steady-state AUC(0-12), Cmax, and tmax of the bupropion metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) when WELLBUTRIN SR is administered alone and with GSK189075.
Measured: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Steady-state AUC(0-12), Cmax, and tmax of GSK189075, and GSK279782 when GSK189075 is administered alone and with WELLBUTRIN SR.
Measured: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs and clinical laboratory assessments, including urine electrolytes (Na, Cl, K, Ca and Mg).
Measured: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Urine volume, urine glucose concentration, and urine creatinine concentration to determine fractional urine glucose excretion over a specified time interval (0-24h).
Measured: Up to Week 12
Hunger and craving will be assessed using two assessment tools: (1) a questionnaire to assess hunger and craving; and (2) a Visual Analogue Scale (VAS) to assess hunger.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start16 Jan 2008
- Primary completion10 Apr 2008
- Study completion10 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625859
- Sponsor's protocol ID
- KGW111083
- Status last verified
- Aug 2017
- First submitted
- 19 Feb 2008
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, 6-sequence, 3-period, Crossover Drug Drug Interaction Study to Evaluate the Pharmacokinetics of Wellbutrin SR and GSK189075 When Co-administered or Administered Alone in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00625859
- Acronym / sponsor ID
- KGW111083
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- pharmacodynamics, Healthy adult male volunteers,, pharmacokinetics,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2008 (actual)
- Primary completion
- 10 Apr 2008 (actual)
- Study completion
- 10 Apr 2008 (actual)
- First posted
- 28 Feb 2008 (estimated)
- 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 purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. The results will help to determine if doses of GSK189075 and WELLBUTRIN SR can be safely taken together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence 1 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 2 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 3 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 4 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 5 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 6 | Experimental | Drug: GSK189075, Drug: Bupropion, Drug: PlaceboEligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 18 to 55 years inclusive.
- Body Mass Index (BMI) is between 19-35kg/m2 (inclusive), with a minimum body weight of 45kg.
- Subject must read and write at a comprehension level that is sufficient to provide written informed consent, and be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Subject has provided informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to the initiation of any study procedures.
Key exclusion criteria (56 listed)
- General
- Laboratory
- Clinically significant abnormalities at Screening including:
- Parameter Range
- Heart Rate < 40 and >100 bpm
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 |
|---|---|---|
| GSK189075GSK189075 will be available as film-coated tablets with a dose of 250 milligrams. | Drug | Subjects receiving treatment sequence 1, Subjects receiving treatment sequence 2, Subjects receiving treatment sequence 3, Subjects receiving treatment sequence 4, Subjects receiving treatment sequence 5, Subjects receiving treatment sequence 6 |
| BupropionBupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally. | Drug | Subjects receiving treatment sequence 1, Subjects receiving treatment sequence 2, Subjects receiving treatment sequence 3, Subjects receiving treatment sequence 4, Subjects receiving treatment sequence 5, Subjects receiving treatment sequence 6 |
| PlaceboPlacebo tablets will be given to subjects. | Drug | Subjects receiving treatment sequence 1, Subjects receiving treatment sequence 2, Subjects receiving treatment sequence 3, Subjects receiving treatment sequence 4, Subjects receiving treatment sequence 5, Subjects receiving treatment sequence 6 |
Primary outcome
Blood samples and urine samples
Time frame: on Day 14
8 secondary outcomes
adverse events, heart rate & blood pressure: each visit ecg: screening, days -1, 1, 4, 7, 13, 14, followup lab tests: screening, days -1, 4, 7, 13, 14, followup
Time frame: Up to Week 12
GSK189074 Cmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
Time frame: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Bupropion and GSK189074 tmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
Time frame: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Steady-state AUC(0-12), Cmax, and tmax of the bupropion metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) when WELLBUTRIN SR is administered alone and with GSK189075.
Time frame: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Steady-state AUC(0-12), Cmax, and tmax of GSK189075, and GSK279782 when GSK189075 is administered alone and with WELLBUTRIN SR.
Time frame: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs and clinical laboratory assessments, including urine electrolytes (Na, Cl, K, Ca and Mg).
Time frame: Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours
Urine volume, urine glucose concentration, and urine creatinine concentration to determine fractional urine glucose excretion over a specified time interval (0-24h).
Time frame: Up to Week 12
Hunger and craving will be assessed using two assessment tools: (1) a questionnaire to assess hunger and craving; and (2) a Visual Analogue Scale (VAS) to assess hunger.
Time frame: Up to Week 12
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 24 Aug 2017.
- Results for study KGW111083 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GSK189075 and Bupropion in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline 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 4 inclusion and 56 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 24 Aug 2017. 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?
Blood samples and urine samples (time frame: on Day 14). 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 Aug 2017.