Healthy VolunteersPhase 1NCT02817516
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants
A Phase 1 study testing TAK-828 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 and tolerability of multiple oral doses of TAK-828 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-828
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 22 Aug 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Parts 1 and 2, participant eligibility is determined according to the following criteria prior to entry into the study:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative, signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- The participant is a healthy male, or a healthy female not of child-bearing potential. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (example, defined as at least 1 year since last regular menses, with a follicle-stimulating hormone [FSH] level of greater than (>) 40 international units per liter [IU/L] or at least 5 years since last regular menses confirmed before any study drug is administered).
- For Part 1: the participant is a non-Japanese adult, aged 18 to 55 years (inclusive) at the time of informed consent and first dose of study drug.
- For Part 1: the participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) (inclusive) at Screening.
- For Part 2: the participant is of Japanese descent (born to Japanese parents and grandparents), aged 20 to 55 years (inclusive) at the time of informed consent and first dose of study drug.
- For Part 2: the participant weighs at least 45 kg and has a BMI of 18.5 to 25 kg/m^2 (inclusive) at Screening.
Who cannot join
- For Parts 1 and 2, any participant who meets any of the following criteria will not qualify for entry into the study:
- The participant received any investigational compound within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- The participant used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) before Check-in (Day -1). Herbal supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than or equal to (<=) 1 gram/day. Limited use of nonprescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- The participant is an immediate family member or study-site employee or is in a dependent relationship with a study-site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- The participant has a history or presence of any disease or condition (or there is any finding upon review of the participant's medical history, physical examination, or clinical laboratory tests giving reasonable suspicion of a disease) that could interfere with study participation or safety, contraindicate taking TAK-828 or a similar drug in the same class, or potentially confound the study results (example, history or presence of clinically significant neurologic, cardiovascular, pulmonary, hepatic, hematologic, renal, immunologic, metabolic, musculoskeletal, gastrointestinal, endocrine, or psychiatric disease). It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda medical monitor may be warranted.
- The participant has a known hypersensitivity to any component of the formulation of TAK-828.
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- The participant has an active infection at Screening.
- The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year, or the participant drinks 7 or more drinks/week for females or 14 or more drinks/week for males (1 drink=5 ounces [150 milliliter {mL}] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 6 months before the Screening visit or is unwilling to abstain from alcohol and drugs throughout the study.
- The participant is taking or took any excluded medication, supplements, or food products during the time periods listed in the Prohibited Medications, Foods, and Products table
- If male, the participant intends to donate sperm during the course of this study or for 14 weeks after the last dose of study drug.
- The participant has any condition possibly affecting drug absorption (example, gastrectomy).
- The participant has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years before Screening.
- The participant has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at Screening or has a known history of human immunodeficiency virus (HIV) infection.
- The participant used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days prior to Check-in (Day -1) or cotinine test is positive at Screening or Check-in (Day -1).
- The participant has poor peripheral venous access.
- The participant donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to Day 1.
- The participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator.
- The participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN).
- The participant has a creatine kinase isoenzyme MB (CK-MB) or cardiac troponin above the ULN at Screening or Day -1.
- If female, the participant is of childbearing potential (example, premenopausal, not sterilized).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Doses of TAK-828 in Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.
Read the detailed description
The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively.
The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
Proposed doses:
- Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily
- Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily
All participants will be asked to take the solution at the same time each day throughout the study.
This multi-center trial will be conducted in the United States.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-828, Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-828Drug
TAK-828 solution.
PlaceboDrug
TAK-828 placebo-matching solution.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: TAK-828 15 milligram (mg) | Experimental | TAK-828 15 mg, solution (0.2 milligram per milliliter [mg/mL] or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. Receives: Drug: TAK-828 |
| Part 1: TAK-828 45 mg | Experimental | TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. Receives: Drug: TAK-828 |
| Part 1: TAK-828 75 mg | Experimental | TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. Receives: Drug: TAK-828 |
| Part 1: TAK-828 100 mg | Experimental | TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. Receives: Drug: TAK-828 |
| Part 2: TAK-828 45 mg | Experimental | TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. Receives: Drug: TAK-828 |
| Part 2: TAK-828 100 mg | Experimental | TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. Receives: Drug: TAK-828 |
| Part 1: Placebo | Placebo comparator | TAK-828 placebo-matching solution, orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. Receives: Drug: Placebo |
| Part 2: Placebo | Placebo comparator | TAK-828 placebo-matching solution, orally, twice daily on Days 1-14 in healthy Japanese participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)
Measured: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Measured: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Measured: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose
Measured: Baseline up to 10 days after last dose of study drug (Day 24)
Secondary outcomes (3)
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)
Measured: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F
Measured: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F
Measured: Cohorts 1 and 2: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohort 3: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion22 Aug 2016
- Study completion22 Aug 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817516
- Sponsor's protocol ID
- TAK-828-1002
- Other IDs
- U1111-1177-8105
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2016
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Doses of TAK-828 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02817516
- Acronym / sponsor ID
- TAK-828-1002
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 17 Jul 2019
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 and tolerability of multiple oral doses of TAK-828 in healthy participants.
Detailed description
The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively.
The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
Proposed doses:
- Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily
- Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily
All participants will be asked to take the solution at the same time each day throughout the study.
This multi-center trial will be conducted in the United States.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: TAK-828 15 milligram (mg) | Experimental | Drug: TAK-828TAK-828 15 mg, solution (0.2 milligram per milliliter [mg/mL] or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. |
| Part 1: TAK-828 45 mg | Experimental | Drug: TAK-828TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. |
| Part 1: TAK-828 75 mg | Experimental | Drug: TAK-828TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. |
| Part 1: TAK-828 100 mg | Experimental | Drug: TAK-828TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. |
| Part 2: TAK-828 45 mg | Experimental | Drug: TAK-828TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. |
| Part 2: TAK-828 100 mg | Experimental | Drug: TAK-828TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboTAK-828 placebo-matching solution, orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboTAK-828 placebo-matching solution, orally, twice daily on Days 1-14 in healthy Japanese participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For Parts 1 and 2, participant eligibility is determined according to the following criteria prior to entry into the study:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative, signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- The participant is a healthy male, or a healthy female not of child-bearing potential. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (example, defined as at least 1 year since last regular menses, with a follicle-stimulating hormone [FSH] level of greater than (>) 40 international units per liter [IU/L] or at least 5 years since last regular menses confirmed before any study drug is administered).
- For Part 1: the participant is a non-Japanese adult, aged 18 to 55 years (inclusive) at the time of informed consent and first dose of study drug.
Key exclusion criteria (21 listed)
- For Parts 1 and 2, any participant who meets any of the following criteria will not qualify for entry into the study:
- The participant received any investigational compound within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- The participant used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) before Check-in (Day -1). Herbal supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than or equal to (<=) 1 gram/day. Limited use of nonprescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- The participant is an immediate family member or study-site employee or is in a dependent relationship with a study-site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- The participant has a history or presence of any disease or condition (or there is any finding upon review of the participant's medical history, physical examination, or clinical laboratory tests giving reasonable suspicion of a disease) that could interfere with study participation or safety, contraindicate taking TAK-828 or a similar drug in the same class, or potentially confound the study results (example, history or presence of clinically significant neurologic, cardiovascular, pulmonary, hepatic, hematologic, renal, immunologic, metabolic, musculoskeletal, gastrointestinal, endocrine, or psychiatric disease). It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda medical monitor may be warranted.
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-828TAK-828 solution. | Drug | Part 1: TAK-828 100 mg, Part 1: TAK-828 15 milligram (mg), Part 1: TAK-828 45 mg, Part 1: TAK-828 75 mg, Part 2: TAK-828 100 mg, Part 2: TAK-828 45 mg |
| PlaceboTAK-828 placebo-matching solution. | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)
Time frame: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Time frame: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Time frame: Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose
Time frame: Baseline up to 10 days after last dose of study drug (Day 24)
3 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)
Time frame: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F
Time frame: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F
Time frame: Cohorts 1 and 2: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohort 3: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Screening Protocol
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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 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-828 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 8 inclusion and 21 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: stopped early, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United 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 17 Jul 2019). 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 Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Baseline up to 10 days after last dose of study drug (Day 24)). The study lists 5 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 17 Jul 2019.