HealthyPhase 1NCT03882255
A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State
A Phase 1 study testing Ponesimod dose range (2 - 20 mg) and Propranolol 80 mg in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.
Trial summary
The primary purpose of this study is to evaluate the effect of the up-titration regimen of ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated to healthy adult participants receiving propranolol at steady state. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ponesimod dose range (2 - 20 mg) and Propranolol 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2019to 26 Aug 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systolic blood pressure (SBP) 90 to 140 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) 50 to 90 mmHg measured on the right arm in supine position after at least 5 minutes rest in the supine position at screening, on Day 1 of the Treatment Period 1, and on Day -2 of Treatment Period 2
- Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2 ) (inclusive) at screening and body weight not less than 50.0 kg
- 12-lead safety electrocardiogram (ECG) without clinically relevant abnormalities at screening, on Day 1 of the Treatment Period 1, and on Day-2 of Treatment Period 2, including:
- QT interval corrected for heart rate using the Fridericia correction (QTcF) of less than or equal to (=<) 450 millisecond (ms) for male participants and =< 470 ms for female participants
- Heart rate (HR) 55 to 100 Beats per minute (bpm) (inclusive)
- QRS interval less than (<) 120 ms
Show all 10Show fewer
- PR interval =< 200 ms
- ECG morphology consistent with healthy cardiac conduction and function
- Female participant must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta- hCG]) pregnancy test at screening and a negative urine pregnancy test on Day 1 of Treatment Period 1 and Day 2 of Treatment Period 2
- Negative results from urine drug screen at screening, on Day -1 of Treatment Period 1, and on Day -2 of Treatment Period 2
Who cannot join
- Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the participant based on medical history, physical examination, 12-lead safety ECG, or 24-hour Holter ECG at screening, including:
- 24-hour Holter ECG with clinically relevant abnormalities
- History or evidence of Atrioventricular (AV) block second degree or higher
- Any cardiac condition or illness (including ECG abnormalities based on standard 12-lead safety ECG or d- 24-hour Holter ECG) with a potential to increase the cardiac risk of the participant
- Family history of sick-sinus syndrome
- Hepatitis A antibody immunoglobulin M (IgM) positive, positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus [anti-HCV]) tests, or other clinically active liver disease at screening
- Known hypersensitivity to any excipients of the ponesimod drug formulation (lactose, microcrystalline cellulose, povidone, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, opadry II brown), or lactose
- History of significant propranolol side effects or known hypersensitivity to propranolol or to any of its excipients
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, 2060
About this study
Official title: A Randomized, Double-blind, Parallel-group, 2-period, Placebo-controlled, Phase 1 Study to Investigate the Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of the Up-titration Regimen of Ponesimod in Healthy Adult Subjects Receiving Propranolol at Steady State
The primary purpose of this study is to evaluate the effect of the up-titration regimen of ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated to healthy adult participants receiving propranolol at steady state.
- Conditions
- Healthy
- Being tested
- Ponesimod dose range (2 - 20 mg), Placebo Propranolol, Propranolol 80 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponesimod dose range (2 - 20 mg)Drug
Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2.
Placebo PropranololDrug
Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2.
Propranolol 80 mgDrug
Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1: Ponesimod (2 mg) | Experimental | Participants will receive a single dose ponesimod 2 milligram (mg) oral tablet under fed conditions on Day 1. Participants not fulfilling discontinuation criteria can continue to Treatment Period 2 after a washout period of at least 7 days and a maximum of 14 days. Receives: Drug: Ponesimod dose range (2 - 20 mg) |
| Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol | Experimental | Participants who do not fulfill any of discontinuation criteria will be randomized to 1 of 2 Treatments (Treatment A or B) on Day 1. Treatment A: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus placebo propranolol once daily from Day 1 to Day 19; Treatment B: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus 80 mg propranolol once daily from Day 1 to Day 19. Receives: Drug: Ponesimod dose range (2 - 20 mg); Drug: Placebo Propranolol; Drug: Propranolol 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Day 5
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Measured: Baseline and Day 5
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Day 19
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Measured: Baseline and Day 19
Minimum of the Mean Hourly HR for each day (HR nadir) on Day 5
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
Measured: Day 5
Minimum of the Mean Hourly HR for each day (HR nadir) on Day 19
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
Measured: Day 19
Secondary outcomes (15)
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Days 4,16, and 19
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Measured: Baseline, Days 4, 16, and 19
Minimum of the Mean Arterial Blood Pressure
Minimum of the Mean arterial blood pressure (MAP) will be assessed. The MAP will be derived from the systolic blood pressure (SBP) and diastolic blood pressure (DBP) for each participant at the same time point as follows: MAP = 1/3 SBP + 2/3 DBP.
Measured: Days 4, 5, 16, and 19
Change from Baseline in Average Heart Rate
Change from baseline in average heart rate on Days 4, 5, 16 and 19 will be assessed in Treatment Period 2.
Measured: Baseline, Days 4, 5, 16, and 19
Change from Baseline in Average PR Interval
Change from baseline in PR interval on Days 4, 5, 16 and 19 will be assessed in Treatment Period 2. PR intervals will be derived from 12-lead safety electrocardiogram (ECG).
Measured: Baseline, Days 4, 5, 16, and 19
Maximum Observed Plasma Analyte Concentration (Cmax) of Ponesimod
Cmax is defined as maximum observed plasma analyte concentration.
Measured: Days 5, 9 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Tmax) of Ponesimod
Tmax is defined as maximum observed plasma analyte concentration.
Measured: Days 5, 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Plasma Analyte Concentration-Time Curve (AUC [0-24]) of Ponesimod
(AUC [0-24]) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.
Measured: Day 5 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 Hours postdose)
Trough Plasma Analyte Concentration (Ctrough) of Ponesimod
(Ctrough) is defined as observed analyte concentration just prior to the beginning of a dosing interval.
Measured: Day 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ) at steady state, calculated by linear-linear trapezoidal summation.
Measured: Day 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Cmax) of Propranolol and 4 hydroxypropranolol
Cmax is defined as maximum observed plasma analyte concentration.
Measured: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Tmax) of Propranolol and 4 hydroxypropranolol
Tmax is defined as maximum observed plasma analyte concentration.
Measured: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Trough Plasma Analyte Concentration (Ctrough) of Propranolol and 4 hydroxypropranolol
(Ctrough) is defined as observed analyte concentration just prior to the beginning of a dosing interval.
Measured: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) of Propranolol and 4 hydroxypropranolol
The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ) at steady state, calculated by linear-linear trapezoidal summation.
Measured: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Total apparent Oral Clearance of Propranolol
Total apparent clearance is defined as total apparent oral clearance at steady state, calculated as dose/AUC (tau).
Measured: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any adverse change, that is, any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease, that occurs in a participant during the course of the study, whether or not considered related to the study treatment.
Measured: Approximately 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Mar 2019
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study director, Janssen Pharmaceutica N.V., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882255
- Sponsor's protocol ID
- CR108589
- Other IDs
- 2018-003550-24, AC-058-117, 2018
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, 2-period, Placebo-controlled, Phase 1 Study to Investigate the Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of the Up-titration Regimen of Ponesimod in Healthy Adult Subjects Receiving Propranolol at Steady State
- ClinicalTrials.gov ID
- NCT03882255
- Acronym / sponsor ID
- CR108589
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 20 Mar 2019 (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.
The primary purpose of this study is to evaluate the effect of the up-titration regimen of ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated to healthy adult participants receiving propranolol at steady state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1: Ponesimod (2 mg) | Experimental | Drug: Ponesimod dose range (2 - 20 mg)Participants will receive a single dose ponesimod 2 milligram (mg) oral tablet under fed conditions on Day 1. Participants not fulfilling discontinuation criteria can continue to Treatment Period 2 after a washout period of at least 7 days and a maximum of 14 days. |
| Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol | Experimental | Drug: Ponesimod dose range (2 - 20 mg), Drug: Placebo Propranolol, Drug: Propranolol 80 mgParticipants who do not fulfill any of discontinuation criteria will be randomized to 1 of 2 Treatments (Treatment A or B) on Day 1. Treatment A: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus placebo propranolol once daily from Day 1 to Day 19; Treatment B: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus 80 mg propranolol once daily from Day 1 to Day 19. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systolic blood pressure (SBP) 90 to 140 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) 50 to 90 mmHg measured on the right arm in supine position after at least 5 minutes rest in the supine position at screening, on Day 1 of the Treatment Period 1, and on Day -2 of Treatment Period 2
- Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2 ) (inclusive) at screening and body weight not less than 50.0 kg
- 12-lead safety electrocardiogram (ECG) without clinically relevant abnormalities at screening, on Day 1 of the Treatment Period 1, and on Day-2 of Treatment Period 2, including:
- Female participant must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta- hCG]) pregnancy test at screening and a negative urine pregnancy test on Day 1 of Treatment Period 1 and Day 2 of Treatment Period 2
- Negative results from urine drug screen at screening, on Day -1 of Treatment Period 1, and on Day -2 of Treatment Period 2
Key exclusion criteria (8 listed)
- Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the participant based on medical history, physical examination, 12-lead safety ECG, or 24-hour Holter ECG at screening, including:
- Family history of sick-sinus syndrome
- Hepatitis A antibody immunoglobulin M (IgM) positive, positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus [anti-HCV]) tests, or other clinically active liver disease at screening
- Known hypersensitivity to any excipients of the ponesimod drug formulation (lactose, microcrystalline cellulose, povidone, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, opadry II brown), or lactose
- History of significant propranolol side effects or known hypersensitivity to propranolol or to any of its excipients
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 |
|---|---|---|
| Ponesimod dose range (2 - 20 mg)Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2. | Drug | Treatment Period 1: Ponesimod (2 mg), Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol |
| Placebo PropranololParticipants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2. | Drug | Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol |
| Propranolol 80 mgParticipants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2. | Drug | Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol |
Primary outcome
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Day 5
Time frame: Baseline and Day 5
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Day 19
Time frame: Baseline and Day 19
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Minimum of the Mean Hourly HR for each day (HR nadir) on Day 5
Time frame: Day 5
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
Minimum of the Mean Hourly HR for each day (HR nadir) on Day 19
Time frame: Day 19
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
15 secondary outcomes
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Days 4,16, and 19
Time frame: Baseline, Days 4, 16, and 19
Minimum of the Mean Arterial Blood Pressure
Time frame: Days 4, 5, 16, and 19
Change from Baseline in Average Heart Rate
Time frame: Baseline, Days 4, 5, 16, and 19
Change from Baseline in Average PR Interval
Time frame: Baseline, Days 4, 5, 16, and 19
Maximum Observed Plasma Analyte Concentration (Cmax) of Ponesimod
Time frame: Days 5, 9 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Tmax) of Ponesimod
Time frame: Days 5, 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Plasma Analyte Concentration-Time Curve (AUC [0-24]) of Ponesimod
Time frame: Day 5 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 Hours postdose)
Trough Plasma Analyte Concentration (Ctrough) of Ponesimod
Time frame: Day 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Day 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Cmax) of Propranolol and 4 hydroxypropranolol
Time frame: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Maximum Observed Plasma Analyte Concentration (Tmax) of Propranolol and 4 hydroxypropranolol
Time frame: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Trough Plasma Analyte Concentration (Ctrough) of Propranolol and 4 hydroxypropranolol
Time frame: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) of Propranolol and 4 hydroxypropranolol
Time frame: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Total apparent Oral Clearance of Propranolol
Time frame: Days 4, 5, and 19 (Predose; 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 2.5 months
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 27 Apr 2025.
- To learn how to participate in this trial please click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Pharmaceutica N.V., Belgium Clinical Trial study director
Janssen Pharmaceutica N.V., Belgium
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 Ponesimod dose range (2 - 20 mg) and Propranolol 80 mg in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.
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 10 inclusion and 8 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 27 Apr 2025. 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 Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Decrease from Baseline in Mean Hourly Heart Rate (HR) (Emax HR) on Day 5 (time frame: Baseline and Day 5). The study lists 4 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 27 Apr 2025.