Healthy VolunteersPhase 1NCT04978298
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
A Phase 1 study testing Rasigiline, Phenelzine and Ozanimod in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the United States (US). Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Rasigiline, Phenelzine and Ozanimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 26 Feb 2023
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must satisfy the following criteria to be enrolled in the study:
- Be a male or non-pregnant, non-lactating female, 25 to 55 years of age, inclusive, at the time of signing the informed consent form.
- Must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
- Is willing and able to adhere to the study visit schedule and other protocol requirements.
- Female participant must meet at least 1 of the following criteria:
- Have a negative serum pregnancy test at Screening and Day -1 (females of child-bearing potential only).
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- Be postmenopausal (defined as 2 years after the last period and follicle-stimulating hormone > 40 IU/L).
- Have received surgical sterilization (eg, bilateral tubal ligation, bilateral oophorectomy, hysterectomy) at least 6 months before Screening.
- Female of child-bearing potential:
- Must agree to practice a highly effective method of contraception at least 28 days prior to first dose of investigational product until completion of the 90-day safety follow-up period. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
- Examples of acceptable methods of birth control in this study are the following:
- Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
- Placement of an intrauterine device or intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomised partner
- Complete sexual abstinence Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- Has a body weight of at least 110 pounds (50 kg); body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.
- Is in good health, as determined by no clinically significant findings from medical or surgical history, 12-lead ECG, PE, clinical laboratory safety tests, and vital signs.
- Has a mean systolic blood pressure (SBP) of 90 to 139 mm Hg, a diastolic blood pressure (DBP) of 50 to 89 mm Hg from three consecutive measurements at Screening and Day -1.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- an unstable SBP (ie, SBP exceeds a maximum range of 15 mm Hg between the lowest and highest values in three consecutive measurements within 15 minutes during Screening).
- the presence or history of any clinically relevant abnormality, condition, or disease (such as glaucoma, liver disease or abnormal liver function tests, cardiovascular or pulmonary diseases) that, in the opinion of the Investigator, may affect absorption, distribution, metabolism, or elimination of the IPs, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if he/she were to participate in the study.
- any condition that confounds the ability to interpret data from the study.
- history of bipolar, depression or suicidal ideation or behavior, or a history of psychiatric illnesses.
- history of clinically significant or unstable vascular disease, a history of syncope associated with hypotension within the last 2 years, a history of orthostatic hypotension (ie, SBP decrease of > 20 mm Hg between 2 and 5 minutes after standing compared with supine SBP), or a history of tachycardia or hypertension.
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- an estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 according to the 2009 chronic kidney disease (CKD) epidemiology collaboration (CKD EPI) equation: eGFR = 141 × min(Scr/κ, 1) × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if African American] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
- a seated heart rate outside 55 to 95 beats per minute at Screening or Day -1.
- a resting QTcF > 450 msec (males) or > 470 msec (females) or PR interval > 210 msec at Screening or Day -1 or at additional risk for QT interval prolongation.
- a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) > 8%.
- a history of uveitis (within the last year prior to Screening) or clinically confirmed diagnosis of macular edema.
- a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
- a known active bacterial, viral, fungal (excluding fungal infection of nail beds, minor upper respiratory tract infections, and minor skin infections), mycobacterial infection (including tuberculosis or atypical mycobacterial disease) or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening.
- In the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on Investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
- a positive serum test for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus .
- used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to the first dose of IP.
- consumed marijuana products within 3 months prior to the first dose of IP.
- a positive urine drug test including cotinine at Screening or Day -1.
- a positive alcohol breath or urine test at Screening or Day -1.
- received any investigational drug within 30 days or 5 times the elimination half-life (if known), whichever is longer, prior to the first dose of IP.
- received a live or live attenuated vaccine within 4 weeks prior to the first dose of IP.
- used any over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multi-vitamins), octopamine within 14 days prior to the first dose of IP. St. John's wort must be discontinued at least 28 days prior to the first dose of IP.
- used any systemic prescription medication (excluding hormonal contraceptives) within 28 days or 5 times the elimination half-life, whichever is longer, prior to the first dose of IP.
- used any MAO inhibitors within 90 days prior to the first dose of IP.
- a history of allergic reaction to tyramine, phenelzine, rasagiline, or S1P agonist.
- a history of adverse reactions to tyramine-containing foods.
- ingested alcohol within 7 days prior to the first dose of IP.
- fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to the first dose of IP.
- poor peripheral venous access.
- donated greater than 400 mL of blood within 60 days prior to Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Ozanimod on Pressor Response to Oral Tyramine in Healthy Adult Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the United States (US).
Period 1 will consist of daily escalating doses of tyramine administered until tyramine pressor response (defined as the tyramine dose required to increase systolic blood pressure by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4 hours after tyramine dosing) is achieved or Day 7.
Read more
Participants who achieve tyramine pressor response at tyramine doses >/= 200mg and </= 700mg are eligible for continuation into Period 2 and will be randomized accordingly.
Depending on the group to which a participant is randomized, participants will receive rasagiline, phenelzine, ozanimod (therapeutic dose), ozanimod (supra-therapeutic dose), or placebo in Period 2. The duration of dosing depends on the group to which a participant is randomized.
In Period 3, all participants will undergo a sham tyramine challenge and receive a single dose of tyramine placebo. Participants who do not achieve tyramine pressor response following the sham challenge will continue with the tyramine challenge (ie, tyramine pressor tests) for up to 12 additional days.
Participants who receive at least one dose of study drug in Period 2 will participate in a follow-up phase during which 2 follow-up telephone calls will be performed, the last of which will occur approximately 80 to 100 days after the last dose of study drug.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, Rasigiline, Phenelzine, Ozanimod
- Keywords
- Healthy Volunteers, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo
RasigilineDrug
Rasigiline
PhenelzineDrug
Phenelzine
OzanimodDrug
Ozanimod
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline group | Experimental | Participants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72. Receives: Other: Placebo; Drug: Rasigiline |
| Phenelzine group | Experimental | Participants will receive phenelzine twice daily (BID) for 14 days from Days 59 to 72. Receives: Other: Placebo; Drug: Phenelzine |
| Ozanimod Therapeutic group | Experimental | Participants will receive ozanimod QD for 65 days (including the initial 7-day dose escalation) from Days 8 to 72. Receives: Other: Placebo; Drug: Ozanimod |
| Ozanimod Supra-therapeutic group | Experimental | Participants will receive ozanimod QD for 65 days (including the initial 10-day dose escalation) from Days 8 to 72. Receives: Other: Placebo; Drug: Ozanimod |
| Placebo | Placebo comparator | Participants will receive matched appropriate placebos from Days 8 to 72. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tyramine Sensitivity Factor (TSF)
The ratio of Tyramine pressor response (Tyr30) in Period 1 over Tyr30 in Period 3.
Measured: Up to Day 85
Secondary outcomes (20)
Heart Rate (HR)
Will be summarized descriptively by period, treatment group, day, and nominal time (where appropriate) using the per protocol (PP) population.
Measured: Up to Day 85
Systolic Blood Pressure (SBP)
Will be summarized descriptively by period, treatment group, day, and nominal time (where appropriate) using the per protocol (PP) population.
Measured: Up to Day 85
Diastolic Blood Pressure (DBP)
Will be summarized descriptively by period, treatment group, day, and nominal time (where appropriate) using the per protocol (PP) population.
Measured: Up to Day 85
CC112273 Pharmacokinetics: Cmax
Maximum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
CC112273 Pharmacokinetics: Cmin
Minimum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
CC112273 Pharmacokinetics: Tmax
Time to Cmax.
Measured: Up to Day 85
CC112273 Pharmacokinetics: AUC0-24
Area under the concentration-time curve from time 0 to 24 hours.
Measured: Up to Day 85
CC112273 Pharmacokinetics: Ctrough
Predose or trough concentration.
Measured: Up to Day 85
CC1084037 Pharmacokinetics: Cmax
Maximum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
CC1084037 Pharmacokinetics: Cmin
Minimum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
CC1084037 Pharmacokinetics: Tmax
Time to Cmax.
Measured: Up to Day 85
CC1084037 Pharmacokinetics: AUC0-24
Area under the concentration-time curve from time 0 to 24 hours.
Measured: Up to Day 85
CC1084037 Pharmacokinetics: Ctrough
Predose or trough concentration.
Measured: Up to Day 85
Ozanimod Pharmacokinetics: Cmax
Maximum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
Ozanimod Pharmacokinetics: Cmin
Minimum observed plasma concentration within the dosing interval.
Measured: Up to Day 85
Ozanimod Pharmacokinetics: Tmax
Time to Cmax.
Measured: Up to Day 85
Ozanimod Pharmacokinetics: AUC0-24
Area under the concentration-time curve from time 0 to 24 hours.
Measured: Up to Day 85
Ozanimod Pharmacokinetics: Ctrough
Predose or trough concentration.
Measured: Up to Day 85
Pharmacokinetics for tyramine: Cave
Average observed plasma concentration within the dosing interval.
Measured: Up to Day 85
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From screening until at least 90 days after last dose of study treatment (except for participants who discontinue from the study during Period 1 in which case AEs will be recorded from screening until 24 hours after the last dose of tyramine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start19 Jul 2021
- Primary completion26 Feb 2023
- Study completion26 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Attanasio, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978298
- Sponsor's protocol ID
- RPC-1063-CP-005
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Ozanimod on Pressor Response to Oral Tyramine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04978298
- Acronym / sponsor ID
- RPC-1063-CP-005
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 26 Feb 2023 (actual)
- Study completion
- 26 Feb 2023 (actual)
- First posted
- 27 Jul 2021 (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 Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the United States (US).
Period 1 will consist of daily escalating doses of tyramine administered until tyramine pressor response (defined as the tyramine dose required to increase systolic blood pressure by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4 hours after tyramine dosing) is achieved or Day 7.
Participants who achieve tyramine pressor response at tyramine doses >/= 200mg and </= 700mg are eligible for continuation into Period 2 and will be randomized accordingly.
Depending on the group to which a participant is randomized, participants will receive rasagiline, phenelzine, ozanimod (therapeutic dose), ozanimod (supra-therapeutic dose), or placebo in Period 2. The duration of dosing depends on the group to which a participant is randomized.
In Period 3, all participants will undergo a sham tyramine challenge and receive a single dose of tyramine placebo. Participants who do not achieve tyramine pressor response following the sham challenge will continue with the tyramine challenge (ie, tyramine pressor tests) for up to 12 additional days.
Participants who receive at least one dose of study drug in Period 2 will participate in a follow-up phase during which 2 follow-up telephone calls will be performed, the last of which will occur approximately 80 to 100 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rasagiline group | Experimental | Other: Placebo, Drug: RasigilineParticipants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72. |
| Phenelzine group | Experimental | Other: Placebo, Drug: PhenelzineParticipants will receive phenelzine twice daily (BID) for 14 days from Days 59 to 72. |
| Ozanimod Therapeutic group | Experimental | Other: Placebo, Drug: OzanimodParticipants will receive ozanimod QD for 65 days (including the initial 7-day dose escalation) from Days 8 to 72. |
| Ozanimod Supra-therapeutic group | Experimental | Other: Placebo, Drug: OzanimodParticipants will receive ozanimod QD for 65 days (including the initial 10-day dose escalation) from Days 8 to 72. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive matched appropriate placebos from Days 8 to 72. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Be a male or non-pregnant, non-lactating female, 25 to 55 years of age, inclusive, at the time of signing the informed consent form.
- Must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
- Is willing and able to adhere to the study visit schedule and other protocol requirements.
- Female participant must meet at least 1 of the following criteria:
- Female of child-bearing potential:
Key exclusion criteria (30 listed)
- an unstable SBP (ie, SBP exceeds a maximum range of 15 mm Hg between the lowest and highest values in three consecutive measurements within 15 minutes during Screening).
- the presence or history of any clinically relevant abnormality, condition, or disease (such as glaucoma, liver disease or abnormal liver function tests, cardiovascular or pulmonary diseases) that, in the opinion of the Investigator, may affect absorption, distribution, metabolism, or elimination of the IPs, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if he/she were to participate in the study.
- any condition that confounds the ability to interpret data from the study.
- history of bipolar, depression or suicidal ideation or behavior, or a history of psychiatric illnesses.
- history of clinically significant or unstable vascular disease, a history of syncope associated with hypotension within the last 2 years, a history of orthostatic hypotension (ie, SBP decrease of > 20 mm Hg between 2 and 5 minutes after standing compared with supine SBP), or a history of tachycardia or hypertension.
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 |
|---|---|---|
| PlaceboPlacebo | Other | Ozanimod Supra-therapeutic group, Ozanimod Therapeutic group, Phenelzine group, Placebo, Rasagiline group |
| RasigilineRasigiline | Drug | Rasagiline group |
| PhenelzinePhenelzine | Drug | Phenelzine group |
| OzanimodOzanimod | Drug | Ozanimod Supra-therapeutic group, Ozanimod Therapeutic group |
Primary outcome
Tyramine Sensitivity Factor (TSF)
Time frame: Up to Day 85
The ratio of Tyramine pressor response (Tyr30) in Period 1 over Tyr30 in Period 3.
20 secondary outcomes
Heart Rate (HR)
Time frame: Up to Day 85
Systolic Blood Pressure (SBP)
Time frame: Up to Day 85
Diastolic Blood Pressure (DBP)
Time frame: Up to Day 85
CC112273 Pharmacokinetics: Cmax
Time frame: Up to Day 85
CC112273 Pharmacokinetics: Cmin
Time frame: Up to Day 85
CC112273 Pharmacokinetics: Tmax
Time frame: Up to Day 85
CC112273 Pharmacokinetics: AUC0-24
Time frame: Up to Day 85
CC112273 Pharmacokinetics: Ctrough
Time frame: Up to Day 85
CC1084037 Pharmacokinetics: Cmax
Time frame: Up to Day 85
CC1084037 Pharmacokinetics: Cmin
Time frame: Up to Day 85
CC1084037 Pharmacokinetics: Tmax
Time frame: Up to Day 85
CC1084037 Pharmacokinetics: AUC0-24
Time frame: Up to Day 85
CC1084037 Pharmacokinetics: Ctrough
Time frame: Up to Day 85
Ozanimod Pharmacokinetics: Cmax
Time frame: Up to Day 85
Ozanimod Pharmacokinetics: Cmin
Time frame: Up to Day 85
Ozanimod Pharmacokinetics: Tmax
Time frame: Up to Day 85
Ozanimod Pharmacokinetics: AUC0-24
Time frame: Up to Day 85
Ozanimod Pharmacokinetics: Ctrough
Time frame: Up to Day 85
Pharmacokinetics for tyramine: Cave
Time frame: Up to Day 85
Incidence of Adverse Events (AEs)
Time frame: From screening until at least 90 days after last dose of study treatment (except for participants who discontinue from the study during Period 1 in which case AEs will be recorded from screening until 24 hours after the last dose of tyramine)
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 31 Aug 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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Screening Protocol
Pain
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.
Massimo Attanasio, MD study director
Celgene
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 Rasigiline, Phenelzine and Ozanimod in people with Healthy Volunteers, run by Celgene 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 20 inclusion and 30 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 31 Aug 2023. 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 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?
Tyramine Sensitivity Factor (TSF) (time frame: Up to Day 85). 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 31 Aug 2023.