Healthy SubjectsPhase 1NCT02807207
To Evaluate the Cardiac Safety and PK Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects
A Phase 1 study testing A: pacritinib and C: moxifloxacin in people with Healthy Subjects, run by CTI BioPharma at 1 site in United States.
Trial summary
The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF) interval in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- A: pacritinib and C: moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2014
- 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
- healthy males or females, between 18 and 55 years of age, inclusive, who are non-tobacco users;
- with BMI range from 18.0 to 32.0 kg/m2, inclusive;
- normal or not clinically significant 12-lead ECG, in the opinion of the Investigator;
- heart rate of 45 to 90 beats per minute (bpm), inclusive, after 5 minutes in the supine position;
- mean systolic blood pressure <141 mmHg and mean diastolic blood pressure <90 mmHg, average value for each taken in duplicate at Screening (a repeat duplicate set may be performed once at Screening);
- in good health, determined by no clinically significant findings from medical history, physical examination, and vital signs;
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- 7. clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- negative test for selected drugs of abuse (including alcohol) at Screening and at Check-in (Day -1 of Period 1);
- negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative HIV antibody screens;
- females must be non-pregnant and non-lactating, and females not of childbearing potential must be postmenopausal for at least 1 year or surgically sterile (eg, tubal ligation, hysterectomy) for at least 90 days, or agree to use, from the time of signing the informed consent or 10 days prior to Check-in (Day -1) of Period 1 until 30 days after Study Completion (Day 22)/ET, one of the following forms of contraception: non-hormonal intrauterine device (IUD) with spermicide; female condom with spermicide; contraceptive sponge with spermicide; intravaginal system (eg, NuvaRing®); diaphragm with spermicide; cervical cap with spermicide; male sexual partner who agrees to use a male condom with spermicide; sterile sexual partner; or abstinence. Oral, implantable, transdermal, or injectable contraceptives may not be used from the time of signing the informed consent or 10 days prior to Check-in (Day -1) of Period 1 until 14 days after the final dose administration. For all females, the pregnancy test result must be negative at Screening and Check-in (Day -1) of Period 1;
- males will either be sterile or agree to use, from Check-in (Day -1) of Period 1 until 90 days following Study Completion (Day 22)/ET, one of the following approved methods of contraception: male condom with spermicide; sterile sexual partner; or use by female sexual partner of an IUD with spermicide; a female condom with spermicide; a contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives. Subjects will refrain from sperm donation from Check-in (Day -1) of Period 1 until 90 days following Study Completion (Day 22)/ET;
- able to comprehend and willing to sign an Informed Consent Form (ICF).
Who cannot join
- presence of any of the following electrocardiographic abnormalities based on the safety ECG at Screening:
- QTcF interval >450 msec
- unusual T-wave morphology (such as bifid T-wave) or flattened low voltage T-waves
- PR interval >210 msec or <110 msec
- evidence of second- or third-degree atrioventricular block
- electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block, or incomplete LBBB or intraventricular conduction delay or QRS duration >110 msec;
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- history of syncope, cardiac arrest, cardiac arrhythmias, torsades de pointes, structural heart disease, a family history of long QT syndrome, or ongoing cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade >3.0;
- history or clinical manifestation of clinically significant cardiovascular, pulmonary, hepatic (eg, hepatitis), renal, hematologic, gastrointestinal (eg, celiac disease, peptic ulcer, gastroesophageal reflux, inflammatory bowel disease), metabolic, allergic, dermatological, neurological, or psychiatric disorder (as determined by the Investigator; appendectomy and cholecystectomy are not considered to be clinically significant disease);
- significant abnormalities in liver function tests (any/all of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >1.5 x upper limit of normal [ULN]; gamma-glutamyl transferase >2 x ULN; or total bilirubin >1.3 x ULN), kidney function tests (serum creatinine > ULN), hypokalemia (defined as serum potassium <3.0 mEq/L) that is persistent and refractory to correction, or hypomagnesemia (defined as serum magnesium <1.4 mEq/L);
- history of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps;
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed;
- history of Gilbert's Syndrome;
- history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
- history of alcoholism or drug addiction within 1 year prior to Check-in (Day -1) of Period 1;
- use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) of Period 1 and during the entire study;
- consumption of alcohol- or caffeine-containing foods and beverages for 72 hours prior to Screening and during the entire study;
- consumption of grapefruit-containing foods and beverages or other potent cytochrome P450 (CYP)3A4 inhibitors for 72 hours prior to Screening and during the entire study;
- participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days prior to Check-in (Day -1) of Period 1, whichever is longer, and during the entire study;
- use of oral, implantable, injectable, or transdermal contraceptives within 10 days prior to Check-in (Day -1) of Period 1 or from the time of signing the informed consent (females only) until 14 days after the final dose administration;
- use of any prescription medications and/or products within 14 days prior to Check-in (Day -1) of Period 1 and during the entire study;
- use of any over-the-counter, non-prescription medications, vitamins, or minerals within 7 days prior to Check-in (Day -1) of Period 1 and during the entire study;
- use of phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in (Day -1) of Period 1 and during the entire study;
- poor peripheral venous access;
- donation of blood from 30 days prior to Screening through Study Completion (Day 22)/ET, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion (Day 22)/ET, inclusive;
- receipt of blood products within 2 months prior to Check-in (Day -1) of Period 1;
- any diarrhea or vomiting during the Screening period or at Check-in (Day -1) of Period 1;
- any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710
About this study
Official title: A Phase 1, Single-Center, Pacritinib- Versus Placebo-Blinded, Active- and Placebo-Controlled, Randomized, 3-Way Crossover Study to Evaluate the Cardiac Safety and Pharmacokinetics Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects
The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF) interval in healthy subjects.
Read the detailed description
This is a randomized, pacritinib- versus placebo-blind, placebo- and active-controlled, single-dose, single-center, 3-period crossover study to evaluate the cardiac safety of a single 400-mg dose of pacritinib compared to placebo, and to characterize the PK of pacritinib and major human metabolites of pacritinib. The study is blinded for pacritinib and placebo, and open-label for moxifloxacin.
Subjects were to receive 3 treatments (400 mg pacritinib, placebo, and 400 mg moxifloxacin) in a crossover fashion. Each treatment is administered as monotherapy during 1 of 3 treatment periods with a 7-day washout period between administration of each study medication. Screening occurred up to 28 days before Check-in (Day -1) of Period 1. On Day -1 of Period 1, subjects checked into the Clinical Research Unit (CRU) for baseline assessments and were confined to the CRU for the remainder of the study until Study Completion (Day 22)/Early Termination. Continuous 12-lead cardiodynamic ECG monitoring and recording was performed from predose (at least
1 hour before administration of study medication) through 24 hours after the administration of study medication, then for 15 minutes every 12 hours (on Days 2 to 7 of each period). Blood samples for PK analysis were also collected predose (Hour 0) and at each cardiodynamic ECG timepoint postdose. Safety endpoints (eg, adverse events [AEs], clinical laboratory evaluations, vital signs) were monitored throughout each period. Subjects were discharged at Study Completion (Day 22). Subjects were scheduled to return for a Follow-up Visit 14 days (±3 days) later on Day 36.
- Conditions
- Healthy Subjects
- Being tested
- A: pacritinib, B: Placebo, C: moxifloxacin
- Keywords
- To Study pharmacokinetics and Cardiac safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: pacritinibDrug
Also called A: pacritinib 400mg
Treatment A
B: PlaceboOther
Treatment B
C: moxifloxacinDrug
Also called C: moxifloxacin 400mg
Treatment C
| Study group | Role | What they receive |
|---|---|---|
| Sequence I | Experimental | treatment sequence: A/B/C Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
| Sequence II | Experimental | treatment sequence: A/C/B Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
| Sequence III | Experimental | treatment sequence: B/A/C Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
| Sequence IV | Experimental | treatment sequence: B/C/A Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
| Sequence V | Experimental | treatment sequence: C/A/B Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
| Sequence VI | Experimental | treatment sequence: C/B/A Receives: Drug: A: pacritinib; Other: B: Placebo; Drug: C: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT calculated using Fridericia correction (QTcF) interval
To evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo
Measured: ECG: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Secondary outcomes (7)
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Treatment emergent Adverse events
To characterize the safety and tolerability of pacritinib following single dose administration in healthy subjects. The frequency of TEAEs is summarized by treatment, MedDRA (version 16.0) system organ class, and preferred term
Measured: Day1 to Day 36
time to Cmax (tmax)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-t)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
AUC extrapolated to infinity (AUC0-∞)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Apparent terminal elimination rate constant (λz)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Apparent terminal elimination half-life (t1/2)
To characterize the pharmacokinetics of pacritinib, moxifloxacin, and major metabolites
Measured: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Kelly Whitehurst, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807207
- Sponsor's protocol ID
- PAC107
- Status last verified
- Jun 2016
- First submitted
- 3 May 2016
- Last updated
- 15 Sep 2023
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Pacritinib- Versus Placebo-Blinded, Active- and Placebo-Controlled, Randomized, 3-Way Crossover Study to Evaluate the Cardiac Safety and Pharmacokinetics Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02807207
- Acronym / sponsor ID
- PAC107
- Conditions
- Healthy Subjects
- Keywords
- To Study pharmacokinetics and Cardiac safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2016 (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.
The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF) interval in healthy subjects.
Detailed description
This is a randomized, pacritinib- versus placebo-blind, placebo- and active-controlled, single-dose, single-center, 3-period crossover study to evaluate the cardiac safety of a single 400-mg dose of pacritinib compared to placebo, and to characterize the PK of pacritinib and major human metabolites of pacritinib. The study is blinded for pacritinib and placebo, and open-label for moxifloxacin.
Subjects were to receive 3 treatments (400 mg pacritinib, placebo, and 400 mg moxifloxacin) in a crossover fashion. Each treatment is administered as monotherapy during 1 of 3 treatment periods with a 7-day washout period between administration of each study medication. Screening occurred up to 28 days before Check-in (Day -1) of Period 1. On Day -1 of Period 1, subjects checked into the Clinical Research Unit (CRU) for baseline assessments and were confined to the CRU for the remainder of the study until Study Completion (Day 22)/Early Termination. Continuous 12-lead cardiodynamic ECG monitoring and recording was performed from predose (at least
1 hour before administration of study medication) through 24 hours after the administration of study medication, then for 15 minutes every 12 hours (on Days 2 to 7 of each period). Blood samples for PK analysis were also collected predose (Hour 0) and at each cardiodynamic ECG timepoint postdose. Safety endpoints (eg, adverse events [AEs], clinical laboratory evaluations, vital signs) were monitored throughout each period. Subjects were discharged at Study Completion (Day 22). Subjects were scheduled to return for a Follow-up Visit 14 days (±3 days) later on Day 36.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence I | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: A/B/C |
| Sequence II | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: A/C/B |
| Sequence III | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: B/A/C |
| Sequence IV | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: B/C/A |
| Sequence V | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: C/A/B |
| Sequence VI | Experimental | Drug: A: pacritinib, Other: B: Placebo, Drug: C: moxifloxacintreatment sequence: C/B/A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- healthy males or females, between 18 and 55 years of age, inclusive, who are non-tobacco users;
- with BMI range from 18.0 to 32.0 kg/m2, inclusive;
- normal or not clinically significant 12-lead ECG, in the opinion of the Investigator;
- heart rate of 45 to 90 beats per minute (bpm), inclusive, after 5 minutes in the supine position;
- mean systolic blood pressure <141 mmHg and mean diastolic blood pressure <90 mmHg, average value for each taken in duplicate at Screening (a repeat duplicate set may be performed once at Screening);
Key exclusion criteria (28 listed)
- presence of any of the following electrocardiographic abnormalities based on the safety ECG at Screening:
- history of syncope, cardiac arrest, cardiac arrhythmias, torsades de pointes, structural heart disease, a family history of long QT syndrome, or ongoing cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade >3.0;
- history or clinical manifestation of clinically significant cardiovascular, pulmonary, hepatic (eg, hepatitis), renal, hematologic, gastrointestinal (eg, celiac disease, peptic ulcer, gastroesophageal reflux, inflammatory bowel disease), metabolic, allergic, dermatological, neurological, or psychiatric disorder (as determined by the Investigator; appendectomy and cholecystectomy are not considered to be clinically significant disease);
- significant abnormalities in liver function tests (any/all of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >1.5 x upper limit of normal [ULN]; gamma-glutamyl transferase >2 x ULN; or total bilirubin >1.3 x ULN), kidney function tests (serum creatinine > ULN), hypokalemia (defined as serum potassium <3.0 mEq/L) that is persistent and refractory to correction, or hypomagnesemia (defined as serum magnesium <1.4 mEq/L);
- history of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps;
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 |
|---|---|---|
| A: pacritinibAlso: A: pacritinib 400mgTreatment A | Drug | Sequence I, Sequence II, Sequence III, Sequence IV, Sequence V, Sequence VI |
| B: PlaceboTreatment B | Other | Sequence I, Sequence II, Sequence III, Sequence IV, Sequence V, Sequence VI |
| C: moxifloxacinAlso: C: moxifloxacin 400mgTreatment C | Drug | Sequence I, Sequence II, Sequence III, Sequence IV, Sequence V, Sequence VI |
Primary outcome
QT calculated using Fridericia correction (QTcF) interval
Time frame: ECG: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
To evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo
7 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Treatment emergent Adverse events
Time frame: Day1 to Day 36
time to Cmax (tmax)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-t)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
AUC extrapolated to infinity (AUC0-∞)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Apparent terminal elimination rate constant (λz)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Apparent terminal elimination half-life (t1/2)
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
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 15 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
Kelly Whitehurst, MD principal investigator
Covance Clinical Research Unit
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 A: pacritinib and C: moxifloxacin in people with Healthy Subjects, run by CTI BioPharma 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 12 inclusion and 28 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 15 Sep 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. 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?
QT calculated using Fridericia correction (QTcF) interval (time frame: ECG: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose). 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 15 Sep 2023.