AcromegalyPhase 1NCT03571594
A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers
A Phase 1 study testing ONO-5788 and Octreotide in people with Acromegaly, run by Ono Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- ONO-5788 and Octreotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 16 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male and female (women of non-child bearing potential, surgically sterile) volunteers, 18-55 years of age, inclusive, at screening (Parts A \& B only).
- Healthy, adult, males and female (women of non-child bearing potential), ≥65 years of age at screening (Part C only).
- Healthy, adult, male, 18-40 years of age, inclusive, at screening (Part D only).
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECG abnormalities (All Parts).
- Body mass index (BMI) of ≥18.5 to ≤30 kg/m2 at screening (Parts A, B \& C).
- Body mass index (BMI) of ≥18.5 to <25 kg/m2 at screening (Part D only).
Who cannot join
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs,excipients or related compounds.
- History or presence of:
- Gallstones, cholangitis, and/or cholecystitis or clinically significant findings on gallbladder ultrasound as determined by the Principal Investigator;
- Pancreatitis;
Show all 21Show fewer
- Hypothyroidism;
- Known diabetes mellitus type 1 or type 2;
- Hypocalcaemia or hypokalemia;
- Hypoglycemia or hyperglycemia or fasting blood glucose outside normal local range;
- Thrombocytopenia or other clinically significant hematologic abnormalities;
- Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery;
- Known vitamin B12 deficiency.
- Abnormal gallbladder ejection fraction on hepatobiliary iminodiacetic acid (HIDA) scan at screening (Part B only)
- Positive urine drug, alcohol or cotinine results at screening or check in.
- Clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or each check-in, in the estimation and clinical judgment of the PI or designee.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg (160/95 mmHg for Part C) at screening.
- Has engaged in strenuous physical exercise in the 48 hours prior first dosing or intends to undergo strenuous physical exercise at any time throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Four- Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-5788 in Healthy Adult Volunteers
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.
Read the detailed description
This single centre study will be comprised of 4 parts, Part A (SAD; up to 7 cohorts, 8 subjects per cohort and including an assessment of food effect), a multiple-dose part (up to 4 doses, 10 subjects per cohort); an elderly cohort (8 subjects per gender) and a proof of principle part.
The single ascending dose part (Part A) comprises of increasing doses of an oral solution or capsule, with an investigation of the potential for food effects.
The multiple ascending dose part (Part B, MAD; 14 days dosing) will be initiated after the PK and safety data are available from the single ascending dose part. Subjects in Part B will have ultrasound scans of the gallbladder during the study and at screening a HIDA scan will be performed. An evaluation of the PK in the elderly and any potential gender differences will also be evaluated in Part C. Subjects in Part C will have an ultrasound of the gallbladder at screening.
Part D will be a proof of principle evaluation where the effects of ONO-5788 to inhibit the GHRH and arginine-stimulated GH release will be evaluated. Octreotide acetate is a reference arm in this part of the study.
- Conditions
- Acromegaly
- Being tested
- ONO-5788, ONO-5788 Placebo, Octreotide
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5788Drug
Investigational drug
ONO-5788 PlaceboDrug
Placebo Comparator
OctreotideDrug
Also called Sandostatin
Active Comparator in Part D
| Study group | Role | What they receive |
|---|---|---|
| ONO-5788 Part A1 | Experimental | Single ascending doses of ONO-5788 or placebo in fasted healthy volunteers randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 |
| ONO-5788 Placebo Part A1 | Placebo comparator | Single ascending doses of ONO-5788 or placebo in fasted healthy volunteers randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 Placebo |
| ONO-5788 Part A2 | Experimental | Single dose (1-2 groups) of ONO-5788 or placebo in healthy volunteers under fed conditions randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 |
| ONO-5788 Placebo Part A2 | Placebo comparator | Single dose (1-2 groups) of ONO-5788 or placebo in healthy volunteers under fed conditions randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 Placebo |
| ONO-5788 Part B | Experimental | Multiple ascending doses of ONO-5788 or placebo in healthy volunteers randomized 8 active : 2 placebo per group Receives: Drug: ONO-5788 |
| ONO-5788 Placebo Part B | Placebo comparator | Multiple ascending doses of ONO-5788 or placebo in healthy volunteers randomized 8 active : 2 placebo per group Receives: Drug: ONO-5788 Placebo |
| ONO-5788 Part C | Experimental | Single doses of ONO-5788 or placebo in elderly female or elderly male healthy volunteers randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 |
| ONO-5788 Placebo Part C | Placebo comparator | Single doses of ONO-5788 or placebo in elderly female or elderly male healthy volunteers randomized 6 active : 2 placebo per group Receives: Drug: ONO-5788 Placebo |
| ONO-5788 Part D | Experimental | Single doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine Receives: Drug: ONO-5788 |
| ONO-5788 Placebo Part D | Placebo comparator | Single doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine Receives: Drug: ONO-5788 Placebo |
| Octreotide Part D | Active comparator | Single doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events by severity
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possible causal relationship.
Measured: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with serious adverse events (SAEs)
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged hospitalization, life-threatening experience or persistent disability.
Measured: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs including pulse/heart rate, respiratory rate, and blood pressure will be reported.
Measured: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with ECG abnormalities
Number of participants with ECG abnormalities will be reported
Measured: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with clinical laboratory abnormalities
Number of participants with clinical laboratory abnormalities will be reported
Measured: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with clinically significant change in ultrasound of gallbladder
Number of participants with clinically significant change in ultrasound of gallbladder will be reported
Measured: Part B - up to day 21
Secondary outcomes (16)
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of ONO-5788 and metabolites (Parts A, B and C only)
Measured: Day 1 through Day 14
Pharmacokinetics (AUC) - food effect
Effect of food on the plasma area under the curve of ONO-5788 and metabolites (Parts A only)
Measured: Day 1
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of ONO-5788, metabolites (Parts A, B, C \& D) and octreotide (Part D only)
Measured: Day 1 through Day 14
Pharmacokinetics (Cmax) - food effect
Effect of food on the maximum observed plasma concentration of ONO-5788, and metabolites (Part A only)
Measured: Day 1
Pharmacokinetics (Tmax)
Assessment of the time to reach Cmax for ONO-5788, metabolites (Parts A, B, C \& D) and octreotide (Part D only)
Measured: Day 1 through Day 14
Pharmacokinetics (Tmax) - food effect
Effect of food on the time to reach Cmax for ONO-5788, metabolites (Part A only)
Measured: Day 1 through Day 14
Pharmacokinetics (Ctrough)
Assessment of trough levels for ONO-5788 and metabolites immediately before dosing (Part B only)
Measured: Day 1 through Day 14
Pharmacokinetics (T1/2)
Assessment of the elimination half-life of ONO-5788 and metabolites (Parts A, B and C only)
Measured: Day 1 through Day 14
Pharmacokinetics (T1/2) - food effect
Effect of food on the elimination half-life of ONO-5788 and metabolites (metabolite) (Part A only)
Measured: Day 1
Pharmacokinetics (CL/F)
Assessment of the apparent clearance rate of ONO-5788 (Parts A \& C)
Measured: Day 1
Pharmacokinetics (CL/F) - food effect
Effect of food on the apparent clearance rate of ONO-5788 (Part A only)
Measured: Day 1
Pharmacokinetics (Cave)
Average concentration of ONO-5788/metabolites/Octreotide (Part D only)
Measured: Day 1
Pharmacodynamics (IGF-1)
Assessment of the effects of ONO-5788 on IGF-1 levels (Part B only)
Measured: Day 1 through Day 21
Pharmacodynamics (Growth Hormone)
Assessment of the effects of ONO-5788 on GH levels (Part B)
Measured: Day 1 through Day 21
Pharmacodynamics (Growth Hormone)
Assessment of the effects of ONO-5788 on GHRH \& arginine stimulated GH levels (Part D)
Measured: Day 1
Pharmacodynamics (IGFBP3)
Assessment of the effects of ONO-5788 on IGFBP3 levels (Part B only)
Measured: Day 1 through Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start7 Jun 2018
- Primary completion16 May 2019
- Study completion16 May 2019
Why it stopped: The study met a pre-defined protocol study stopping criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry O'Reilly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571594
- Sponsor's protocol ID
- ONO-5788-01
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Four- Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-5788 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03571594
- Acronym / sponsor ID
- ONO-5788-01
- Conditions
- Acromegaly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study met a pre-defined protocol study stopping criteria
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.
Detailed description
This single centre study will be comprised of 4 parts, Part A (SAD; up to 7 cohorts, 8 subjects per cohort and including an assessment of food effect), a multiple-dose part (up to 4 doses, 10 subjects per cohort); an elderly cohort (8 subjects per gender) and a proof of principle part.
The single ascending dose part (Part A) comprises of increasing doses of an oral solution or capsule, with an investigation of the potential for food effects.
The multiple ascending dose part (Part B, MAD; 14 days dosing) will be initiated after the PK and safety data are available from the single ascending dose part. Subjects in Part B will have ultrasound scans of the gallbladder during the study and at screening a HIDA scan will be performed. An evaluation of the PK in the elderly and any potential gender differences will also be evaluated in Part C. Subjects in Part C will have an ultrasound of the gallbladder at screening.
Part D will be a proof of principle evaluation where the effects of ONO-5788 to inhibit the GHRH and arginine-stimulated GH release will be evaluated. Octreotide acetate is a reference arm in this part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| ONO-5788 Part A1 | Experimental | Drug: ONO-5788Single ascending doses of ONO-5788 or placebo in fasted healthy volunteers randomized 6 active : 2 placebo per group |
| ONO-5788 Placebo Part A1 | Placebo comparator | Drug: ONO-5788 PlaceboSingle ascending doses of ONO-5788 or placebo in fasted healthy volunteers randomized 6 active : 2 placebo per group |
| ONO-5788 Part A2 | Experimental | Drug: ONO-5788Single dose (1-2 groups) of ONO-5788 or placebo in healthy volunteers under fed conditions randomized 6 active : 2 placebo per group |
| ONO-5788 Placebo Part A2 | Placebo comparator | Drug: ONO-5788 PlaceboSingle dose (1-2 groups) of ONO-5788 or placebo in healthy volunteers under fed conditions randomized 6 active : 2 placebo per group |
| ONO-5788 Part B | Experimental | Drug: ONO-5788Multiple ascending doses of ONO-5788 or placebo in healthy volunteers randomized 8 active : 2 placebo per group |
| ONO-5788 Placebo Part B | Placebo comparator | Drug: ONO-5788 PlaceboMultiple ascending doses of ONO-5788 or placebo in healthy volunteers randomized 8 active : 2 placebo per group |
| ONO-5788 Part C | Experimental | Drug: ONO-5788Single doses of ONO-5788 or placebo in elderly female or elderly male healthy volunteers randomized 6 active : 2 placebo per group |
| ONO-5788 Placebo Part C | Placebo comparator | Drug: ONO-5788 PlaceboSingle doses of ONO-5788 or placebo in elderly female or elderly male healthy volunteers randomized 6 active : 2 placebo per group |
| ONO-5788 Part D | Experimental | Drug: ONO-5788Single doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine |
| ONO-5788 Placebo Part D | Placebo comparator | Drug: ONO-5788 PlaceboSingle doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine |
| Octreotide Part D | Active comparator | Drug: OctreotideSingle doses of ONO-5788, octreotide or placebo in healthy volunteers stimulated with growth hormone release hormone (GHRH) and arginine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, adult, male and female (women of non-child bearing potential, surgically sterile) volunteers, 18-55 years of age, inclusive, at screening (Parts A \& B only).
- Healthy, adult, males and female (women of non-child bearing potential), ≥65 years of age at screening (Part C only).
- Healthy, adult, male, 18-40 years of age, inclusive, at screening (Part D only).
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECG abnormalities (All Parts).
- Body mass index (BMI) of ≥18.5 to ≤30 kg/m2 at screening (Parts A, B \& C).
Key exclusion criteria (21 listed)
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs,excipients or related compounds.
- History or presence of:
- Positive urine drug, alcohol or cotinine results at screening or check in.
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 |
|---|---|---|
| ONO-5788Investigational drug | Drug | ONO-5788 Part A1, ONO-5788 Part A2, ONO-5788 Part B, ONO-5788 Part C, ONO-5788 Part D |
| ONO-5788 PlaceboPlacebo Comparator | Drug | ONO-5788 Placebo Part A1, ONO-5788 Placebo Part A2, ONO-5788 Placebo Part B, ONO-5788 Placebo Part C, ONO-5788 Placebo Part D |
| OctreotideAlso: SandostatinActive Comparator in Part D | Drug | Octreotide Part D |
Primary outcome
Number of participants with treatment emergent adverse events by severity
Time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possible causal relationship.
Number of participants with serious adverse events (SAEs)
Time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged hospitalization, life-threatening experience or persistent disability.
Number of participants with clinically significant changes in vital signs
Time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with clinically significant changes in vital signs including pulse/heart rate, respiratory rate, and blood pressure will be reported.
Number of participants with ECG abnormalities
Time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with ECG abnormalities will be reported
Number of participants with clinical laboratory abnormalities
Time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28
Number of participants with clinical laboratory abnormalities will be reported
Number of participants with clinically significant change in ultrasound of gallbladder
Time frame: Part B - up to day 21
Number of participants with clinically significant change in ultrasound of gallbladder will be reported
16 secondary outcomes
Pharmacokinetics (AUC)
Time frame: Day 1 through Day 14
Pharmacokinetics (AUC) - food effect
Time frame: Day 1
Pharmacokinetics (Cmax)
Time frame: Day 1 through Day 14
Pharmacokinetics (Cmax) - food effect
Time frame: Day 1
Pharmacokinetics (Tmax)
Time frame: Day 1 through Day 14
Pharmacokinetics (Tmax) - food effect
Time frame: Day 1 through Day 14
Pharmacokinetics (Ctrough)
Time frame: Day 1 through Day 14
Pharmacokinetics (T1/2)
Time frame: Day 1 through Day 14
Pharmacokinetics (T1/2) - food effect
Time frame: Day 1
Pharmacokinetics (CL/F)
Time frame: Day 1
Pharmacokinetics (CL/F) - food effect
Time frame: Day 1
Pharmacokinetics (Cave)
Time frame: Day 1
Pharmacodynamics (IGF-1)
Time frame: Day 1 through Day 21
Pharmacodynamics (Growth Hormone)
Time frame: Day 1 through Day 21
Pharmacodynamics (Growth Hormone)
Time frame: Day 1
Pharmacodynamics (IGFBP3)
Time frame: Day 1 through Day 21
Results and safety
The study was stopped early (reason given: The study met a pre-defined protocol study stopping criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry O'Reilly, MD principal investigator
Celerion
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 ONO-5788 and Octreotide in people with Acromegaly, run by Ono Pharmaceutical Co., Ltd. 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 6 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 5 Jun 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?
The study was stopped early (reason given: The study met a pre-defined protocol study stopping criteria). Results are not available in the source record.
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?
Number of participants with treatment emergent adverse events by severity (time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28). The study lists 6 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 5 Jun 2019.