Healthy VolunteersPhase 1NCT02389881
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
A Phase 1 study testing TAK-058 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-058
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages for this study are 18 to 60 years for non-elderly and 18 to 65 years for elderly.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- A female participant with no childbearing potential, which is defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone [FSH]>40 IU/L).
- Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at Screening.
Who cannot join
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has received TAK-058 in a previous clinical study.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has a known hypersensitivity to any component of the formulation of TAK-058.
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 6 months prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Show all 23Show fewer
- Female participants of childbearing potential (premenopausal, non-sterilized), or has a positive pregnancy test.
- Male participants that intend to donate sperm during the course of this study or for 12 weeks thereafter.
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-058, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders and cardiac arrhythmias.
- Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
- Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).
- Has a history of cancer or other malignancy, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV) or a known history of human immunodeficiency virus infection at Screening.
- Has poor peripheral venous access.
- Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
- Has a Screening or Check-in (Day -1) abnormal (clinically significant [CS]) electrocardiogram (ECG).
- Has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 60 to 90 mm Hg for diastolic, confirmed with one repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1) Visit.
- Has a resting heart rate outside the range 50 to 100 bpm, confirmed with repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1) Visit.
- Has a QT interval with Fridericia's correction method (QTcF) >450 ms (males) or >470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1) Visit.
- Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a CS underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.
- Has a risk of suicide according to the investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS]) or has made a suicide attempt in the previous 6 months.
- Has uncontrolled, CS neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.
- Has used nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects After Multiple Oral Doses of TAK-058
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.
Read the detailed description
The drug being tested in this study is TAK-058, which is under evaluation for the treatment of schizophrenia.
This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Cohort 1 Non-elderly Healthy: TAK-058 25 mg
- Cohort 2 Non-elderly Healthy: TAK-058 75 mg
- Cohort 3 Non-elderly Healthy: TAK-058 150 mg
- Cohort 4 Elderly Healthy: TAK-058 25 mg
- Cohort 5 Non-elderly Healthy: TAK-058 300 mg
- Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that looks like the study drug but has no active ingredient.
- Cohort 5 Elderly Placebo This single-center trial will be conducted in the United States. The overall time to participate in this study is 40 days if assigned to Cohort 1 to 4. Participants will be confined to the clinic for 12 days, and will be contacted by telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days 21 and 40).
The overall time to participate in this study is 14 days if assigned to Cohort 5. Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment (Day 14).
- Conditions
- Healthy Volunteers
- Being tested
- TAK-058, TAK-058 Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-058Drug
TAK-058 Solution
TAK-058 PlaceboDrug
TAK-058 placebo-matching solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Non-elderly Healthy: TAK-058 25 mg | Experimental | TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. Receives: Drug: TAK-058 |
| Cohort 2 Non-elderly Healthy: TAK-058 75 mg | Experimental | TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. Receives: Drug: TAK-058 |
| Cohort 3 Non-elderly Healthy: TAK-058 150 mg | Experimental | TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. Receives: Drug: TAK-058 |
| Cohort 4 Elderly Healthy: TAK-058 25 mg | Experimental | TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants. Receives: Drug: TAK-058 |
| Cohort 5 Non-elderly Healthy: TAK-058 300 mg | Placebo comparator | TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants. Receives: Drug: TAK-058 |
| Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo | Placebo comparator | TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants. Receives: Drug: TAK-058 Placebo |
| Cohort 4 Elderly Healthy: Placebo | Placebo comparator | TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. Receives: Drug: TAK-058 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.
Measured: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.
Measured: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Secondary outcomes (4)
Mean Cmax: Maximum Observed Plasma Concentration for TAK-058
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose
Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058
AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.
Measured: Day 1 predose and at multiple time points (up to 72 hours) postdose
Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058
AUC24 is measure of area under the curve from time 0 to 24 hours postdose.
Measured: Day 1 predose and at multiple time points (up to 24 hours) postdose
Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058
Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.
Measured: Day 10 predose and at multiple time points (up to 24 hours) postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389881
- Sponsor's protocol ID
- TAK-058-1002
- Other IDs
- U1111-1165-3644
- Status last verified
- Jan 2017
- First submitted
- 10 Mar 2015
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects After Multiple Oral Doses of TAK-058
- ClinicalTrials.gov ID
- NCT02389881
- Acronym / sponsor ID
- TAK-058-1002
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 23 Feb 2017
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 study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.
Detailed description
The drug being tested in this study is TAK-058, which is under evaluation for the treatment of schizophrenia.
This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Cohort 1 Non-elderly Healthy: TAK-058 25 mg
- Cohort 2 Non-elderly Healthy: TAK-058 75 mg
- Cohort 3 Non-elderly Healthy: TAK-058 150 mg
- Cohort 4 Elderly Healthy: TAK-058 25 mg
- Cohort 5 Non-elderly Healthy: TAK-058 300 mg
- Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that looks like the study drug but has no active ingredient.
- Cohort 5 Elderly Placebo This single-center trial will be conducted in the United States. The overall time to participate in this study is 40 days if assigned to Cohort 1 to 4. Participants will be confined to the clinic for 12 days, and will be contacted by telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days 21 and 40).
The overall time to participate in this study is 14 days if assigned to Cohort 5. Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment (Day 14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Non-elderly Healthy: TAK-058 25 mg | Experimental | Drug: TAK-058TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 2 Non-elderly Healthy: TAK-058 75 mg | Experimental | Drug: TAK-058TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 3 Non-elderly Healthy: TAK-058 150 mg | Experimental | Drug: TAK-058TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 4 Elderly Healthy: TAK-058 25 mg | Experimental | Drug: TAK-058TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants. |
| Cohort 5 Non-elderly Healthy: TAK-058 300 mg | Placebo comparator | Drug: TAK-058TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants. |
| Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo | Placebo comparator | Drug: TAK-058 PlaceboTAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants. |
| Cohort 4 Elderly Healthy: Placebo | Placebo comparator | Drug: TAK-058 PlaceboTAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages for this study are 18 to 60 years for non-elderly and 18 to 65 years for elderly.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- A female participant with no childbearing potential, which is defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone [FSH]>40 IU/L).
- Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at Screening.
Key exclusion criteria (23 listed)
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has received TAK-058 in a previous clinical study.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has a known hypersensitivity to any component of the formulation of TAK-058.
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-058TAK-058 Solution | Drug | Cohort 1 Non-elderly Healthy: TAK-058 25 mg, Cohort 2 Non-elderly Healthy: TAK-058 75 mg, Cohort 3 Non-elderly Healthy: TAK-058 150 mg, Cohort 4 Elderly Healthy: TAK-058 25 mg, Cohort 5 Non-elderly Healthy: TAK-058 300 mg |
| TAK-058 PlaceboTAK-058 placebo-matching solution | Drug | Cohort 4 Elderly Healthy: Placebo, Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo |
Primary outcome
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.
4 secondary outcomes
Mean Cmax: Maximum Observed Plasma Concentration for TAK-058
Time frame: Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose
Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058
Time frame: Day 1 predose and at multiple time points (up to 72 hours) postdose
Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058
Time frame: Day 1 predose and at multiple time points (up to 24 hours) postdose
Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058
Time frame: Day 10 predose and at multiple time points (up to 24 hours) postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- 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.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-058 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 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 23 Feb 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. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2017). 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?
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14). 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 23 Feb 2017.