CardiodynamicsPhase 1NCT02206204
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
A Phase 1 study testing selexipag and moxifloxacin in people with Cardiodynamics and Safety, run by Actelion at 1 site in United States.
Trial summary
This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiodynamics, Safety, Tolerability
- What is being tested?
- selexipag and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed, dated written informed consent prior to any study procedure.
- Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study.
- Women of childbearing potential must have had a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1. Women of childbearing potential must have consistently and correctly used a reliable method of contraception with a failure rate of < 1% per year, been sexually inactive, or have vasectomized partner.
- Healthy based on medical history and assessments performed at screening and on Day -1.
- Body mass index ≥ 18.5 and ≤ 32 kg/m^2 at screening. Body weight at least 50 kg.
- Negative results from urine drug screen at screening and on Day -1 and negative urine alcohol test on Day -1.
Show all 9Show fewer
- Willing to refrain from alcohol consumption from at least 48 hours prior to clinic admission to the end of study.
- Systolic blood pressure 90-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute, at screening and Day -1.
- Hematology, blood chemistry, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening and Day -1.
Who cannot join
- Known hypersensitivity to selexipag, moxifloxacin, or excipients of the drug formulations used in this study.
- Treatment with selexipag or an investigational drug prior to screening within 30 days or 6 half-lives, whichever was longer.
- History or clinical evidence of any disease and/or the existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag and moxifloxacin.
- Caffeine consumption of equal to or greater than 800 mg per day at screening.
- History of fainting, collapse, syncope, blackouts, orthostatic hypotension, or vasovagal reactions.
- Chronic or relevant acute infections.
Show all 23Show fewer
- History of relevant allergy / hypersensitivity.
- History of clinical evidence of psychiatric disease, alcoholism, or drug abuse within the 3-year period prior to screening.
- Smoking within the 3 months prior to screening and inability to refrain from smoking during the study.
- Loss of 500 mL or more of blood within 56 days prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects at screening.
- Positive results from human immunodeficiency virus serology at screening.
- Previous treatment with any prescribed or over-the-counter medications, with the exception of contraceptives and hormone replacement therapy, within the 2 weeks prior to first study drug administration or 5 half-lives, whichever longer.
- Excessive physical activities within 1 week prior to administration of study drug.
- Any cardiac condition (including ECG abnormalities) or illness with a potential to increase the cardiac risk of the subject or that may affect QTc analysis.
- QTc > 450 ms or > 470 ms for male or female subjects, respectively, at screening and Day -1.
- Clinically relevant abnormalities on ECG, at screening and Day -1.
- Personal or family history of long QT syndrome or hypokalemia.
- Legal incapacity or limited legal capacity.
- Veins unsuitable for intravenous puncture on either arm.
- Any circumstances or conditions, which, in the opinion of the investigator, may affected the subject's participation in the study or compliance with the protocol.
- Pregnant or nursing women.
- Women who plan to become pregnant within 1 month of the end of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Evansville, Indiana, 47710
About this study
Official title: Single-center, Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group With Nested Cross-over, Multiple-dose, Up-titration Study of the Effects of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.
- Conditions
- Cardiodynamics, Safety, Tolerability, Pharmacokinetics
- Being tested
- selexipag, placebo for selexipag, moxifloxacin, moxifloxacin-matching placebo
- Keywords
- Selexipag, ACT-333679
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selexipagDrug
placebo for selexipagDrug
moxifloxacinDrug
moxifloxacin-matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects in Group A receive selexipag on Days 3 to 23 and moxifloxacin-matching placebo on Days 2 and 24. Selexipag administered orally, twice a day, for 21 days according to the following multiple dose up-titration regimen: 400 μg on Days 3-5, 600 μg on Days 6-8, 800 μg on Days 9-11, 1000 μg on Days 12-14, 1200 μg on Days 15-17, 1400 μg on Days 18-20, and 1600 μg on Days 21-23 (only morning dose on Day 23). Receives: Drug: selexipag; Drug: moxifloxacin-matching placebo |
| Group B1 | Experimental | Subjects in Group B1 receive 400 mg moxifloxacin, orally on Day 2 and moxifloxacin-matching placebo, orally on Day 24. Subjects receive placebo for selexipag, orally on Days 3 to 23. Receives: Drug: placebo for selexipag; Drug: moxifloxacin; Drug: moxifloxacin-matching placebo |
| Group B2 | Experimental | Subjects in Group B2 receive moxifloxacin-matching placebo, orally on Day 2 and 400 mg moxifloxacin, orally on Day 24. Subjects receive placebo for selexipag, orally on Days 3 to 23. Receives: Drug: placebo for selexipag; Drug: moxifloxacin; Drug: moxifloxacin-matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline adjusted placebo corrected change in corrected QTc interval (time interval from beginning of the Q wave until end of the T wave) (ΔΔQTcI) at various time points
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23. Based on prospective criteria, QTcI will be the primary method for heart rate (HR) correction.
Measured: 24 days
Secondary outcomes (18)
Baseline adjusted placebo corrected change in heart rate at various time points
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23.
Measured: 24 days
Baseline adjusted placebo corrected change in RR interval (interval from the peak of one QRS complex to the peak of the next) at various time points
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23.
Measured: 24 days
Baseline adjusted placebo corrected change in PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) at various time points
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23.
Measured: 24 days
Baseline adjusted placebo corrected change in QRS interval (time interval from the beginning of the Q wave to the end of the S wave) at various time points
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23.
Measured: 24 days
Number of time points at which T-wave morphology changes were observed
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23.
Measured: 24 days
Maximum plasma concentration (Cmax) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. Selexipag concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain Cmax
Measured: 24 days
Time to reach maximum plasma concentration (tmax) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. Selexipag concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain tmax
Measured: 24 days
Area under the plasma concentration-time curve (AUCt) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. Selexipag concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. AUCt will be calculated according to the linear trapezoidal rule, using the measured concentration-time values above the limit of quantification during one dosing interval.
Measured: 24 days
Trough plasma concentration (Ctrough) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. Selexipag concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain Ctrough
Measured: 24 days
Maximum plasma concentration (Cmax) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. ACT-333679 concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain Cmax
Measured: 24 days
Time to reach maximum plasma concentration (tmax) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. ACT-333679 concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain tmax
Measured: 24 days
Area under the plasma concentration-time curve (AUCt) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. ACT-333679 concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. AUCt will be calculated according to the linear trapezoidal rule, using the measured concentration-time values above the limit of quantification during one dosing interval.
Measured: 24 days
Trough plasma concentration (Ctrough) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in a vein in the arm on Days 11 and 23. Samples will be collected immediately prior to morning dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dosing. ACT-333679 concentrations will be quantified in plasma samples by liquid chromatography with tandem mass spectrometry. The measured individual plasma concentrations will be used to directly obtain Ctrough
Measured: 24 days
Change in systolic blood pressure from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). Measurements will be recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: up to 29 days
Change in diastolic blood pressure from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). Measurements will be recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: up to 29 days
Change in pulse rate from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). Measurements will be recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: up to 29 days
Change in body weight from baseline up to end of study
Body weight will be measured using weighing scales with a precision of at least 0.5 kg.
Measured: up to 29 days
Number of participants with treatment-related electrocardiogram abnormalities up to the end of study
Standard 12-lead electrocardiograms (ECGs) will be recorded at screening, on Day -1, Day 11, Day 23, and at end of study.
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiodynamicsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Hoch, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206204
- Sponsor's protocol ID
- AC-065-106
- Status last verified
- Jul 2014
- First submitted
- 30 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group With Nested Cross-over, Multiple-dose, Up-titration Study of the Effects of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02206204
- Acronym / sponsor ID
- AC-065-106
- Conditions
- Cardiodynamics, Safety, Tolerability, Pharmacokinetics
- Keywords
- Selexipag, ACT-333679
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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 single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: selexipag, Drug: moxifloxacin-matching placeboSubjects in Group A receive selexipag on Days 3 to 23 and moxifloxacin-matching placebo on Days 2 and 24. Selexipag administered orally, twice a day, for 21 days according to the following multiple dose up-titration regimen: 400 μg on Days 3-5, 600 μg on Days 6-8, 800 μg on Days 9-11, 1000 μg on Days 12-14, 1200 μg on Days 15-17, 1400 μg on Days 18-20, and 1600 μg on Days 21-23 (only morning dose on Day 23). |
| Group B1 | Experimental | Drug: placebo for selexipag, Drug: moxifloxacin, Drug: moxifloxacin-matching placeboSubjects in Group B1 receive 400 mg moxifloxacin, orally on Day 2 and moxifloxacin-matching placebo, orally on Day 24. Subjects receive placebo for selexipag, orally on Days 3 to 23. |
| Group B2 | Experimental | Drug: placebo for selexipag, Drug: moxifloxacin, Drug: moxifloxacin-matching placeboSubjects in Group B2 receive moxifloxacin-matching placebo, orally on Day 2 and 400 mg moxifloxacin, orally on Day 24. Subjects receive placebo for selexipag, orally on Days 3 to 23. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed, dated written informed consent prior to any study procedure.
- Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study.
- Women of childbearing potential must have had a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1. Women of childbearing potential must have consistently and correctly used a reliable method of contraception with a failure rate of < 1% per year, been sexually inactive, or have vasectomized partner.
- Healthy based on medical history and assessments performed at screening and on Day -1.
- Body mass index ≥ 18.5 and ≤ 32 kg/m^2 at screening. Body weight at least 50 kg.
Key exclusion criteria (23 listed)
- Known hypersensitivity to selexipag, moxifloxacin, or excipients of the drug formulations used in this study.
- Treatment with selexipag or an investigational drug prior to screening within 30 days or 6 half-lives, whichever was longer.
- History or clinical evidence of any disease and/or the existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag and moxifloxacin.
- Caffeine consumption of equal to or greater than 800 mg per day at screening.
- History of fainting, collapse, syncope, blackouts, orthostatic hypotension, or vasovagal reactions.
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 |
|---|---|---|
| selexipag | Drug | Group A |
| placebo for selexipag | Drug | Group B1, Group B2 |
| moxifloxacin | Drug | Group B1, Group B2 |
| moxifloxacin-matching placebo | Drug | Group A, Group B1, Group B2 |
Primary outcome
Baseline adjusted placebo corrected change in corrected QTc interval (time interval from beginning of the Q wave until end of the T wave) (ΔΔQTcI) at various time points
Time frame: 24 days
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23. Based on prospective criteria, QTcI will be the primary method for heart rate (HR) correction.
18 secondary outcomes
Baseline adjusted placebo corrected change in heart rate at various time points
Time frame: 24 days
Baseline adjusted placebo corrected change in RR interval (interval from the peak of one QRS complex to the peak of the next) at various time points
Time frame: 24 days
Baseline adjusted placebo corrected change in PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) at various time points
Time frame: 24 days
Baseline adjusted placebo corrected change in QRS interval (time interval from the beginning of the Q wave to the end of the S wave) at various time points
Time frame: 24 days
Number of time points at which T-wave morphology changes were observed
Time frame: 24 days
Maximum plasma concentration (Cmax) for selexipag
Time frame: 24 days
Time to reach maximum plasma concentration (tmax) for selexipag
Time frame: 24 days
Area under the plasma concentration-time curve (AUCt) for selexipag
Time frame: 24 days
Trough plasma concentration (Ctrough) for selexipag
Time frame: 24 days
Maximum plasma concentration (Cmax) for ACT-333679
Time frame: 24 days
Time to reach maximum plasma concentration (tmax) for ACT-333679
Time frame: 24 days
Area under the plasma concentration-time curve (AUCt) for ACT-333679
Time frame: 24 days
Trough plasma concentration (Ctrough) for ACT-333679
Time frame: 24 days
Change in systolic blood pressure from baseline up to end of study
Time frame: up to 29 days
Change in diastolic blood pressure from baseline up to end of study
Time frame: up to 29 days
Change in pulse rate from baseline up to end of study
Time frame: up to 29 days
Change in body weight from baseline up to end of study
Time frame: up to 29 days
Number of participants with treatment-related electrocardiogram abnormalities up to the end of study
Time frame: up to 29 days
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 1 Aug 2014.
Related trials for Cardiodynamics
Enrolling by invitation
The Study Examined the Acute Effects of Wim Hof on Aerobic Training and Cardiodynamics.
Respiratory Abnormality, Pulmonary
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.
Matthias Hoch, PhD study director
Actelion
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 selexipag and moxifloxacin in people with Cardiodynamics and Safety, run by Actelion 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 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. 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. 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?
Baseline adjusted placebo corrected change in corrected QTc interval (time interval from beginning of the Q wave until end of the T wave) (ΔΔQTcI) at various time points (time frame: 24 days). 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 1 Aug 2014.