Cardiac Conduction and RepolarizationPhase 1NCT01874561
Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization
A Phase 1 study testing Custirsen and Moxifloxacin in people with Cardiac Conduction and Repolarization, run by Achieve Life Sciences at 1 site in United States.
Trial summary
This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized study, to compare treatment with intravenous custirsen at 640 mg (highest intended therapeutic dose) with placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Conduction and Repolarization
- What is being tested?
- Custirsen and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a man aged 18 through 45 years of age with a body mass index (BMI) of 18 through 30 kg/m2 at screening.
- The subject is in good health as determined by medical history, ECG, vital signs measurements, physical examination, and clinical laboratory tests.
- The subject must be able to understand and comply with the requirements of the study (eg, all medication, dietary, exercise, tobacco, and alcohol restrictions).
- The subject must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator or delegate.
- Other inclusion criteria apply.
Who cannot join
- Exclusion criteria related to ECG findings include the following:
- The subject has an ECG abnormality that may interfere with the accurate assessment of the QT interval, including intraventricular conduction delays (QRS >120 msec or PR >200 as measured at the screening and check-in visits) and complete or incomplete bundle branch blocks.
- The subject has a resting QTcF interval of ≤360 msec and/or ≥450 msec measured at screening or day -2.
- Exclusion criteria related to cardiac function include the following:
- The subject has a known clinically significant (in the opinion of the investigator) cardiovascular disorder, including coronary artery disease, valvular heart disease, cardiomyopathies, or an ECG abnormality suggestive of prior myocardial infarction, angina pectoris, chamber enlargement, or hypertrophy. Notwithstanding, subjects with known significant disorders will be excluded.
- The subject has a known clinically significant arrhythmia or rhythm disturbance observed on the screening and/or day -2 12-lead ECG.
Show all 21Show fewer
- The subject has a supine pulse rate outside of the range of 40 to 100 bpm (following at least a 10-minute rest) measured at screening or day -2.
- The subject has a supine blood pressure outside of the range of 90 to 139 mm Hg systolic or 50 to 89 mm Hg diastolic (following at least a 10-minute rest) measured at screening and on day -2. Note: The blood pressure measurement may be repeated up to 3 times to meet eligibility requirements. In this case, the average of these 3 measurements must meet eligibility criteria.
- The subject reports a history of, or risk factors for, Torsades de Pointes (eg, congestive heart failure, serum electrolyte abnormalities) including a family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope.
- The subject has low serum potassium and/or magnesium and/or corrected calcium blood levels (less than 3.5 milliequivalent/liter (mEq/L), 1.8 mEq/L, and 8.9 mg/dL, respectively) at screening and/or day-2.
- The subject has any condition that may possibly interfere with drug absorption, distribution, metabolism, or excretion (eg, previous surgery on the gastrointestinal tract [including removal of parts of stomach, bowel, liver, gall bladder, or pancreas] or stomach banding).
- The subject has an abnormality in medical history, physical examination, biochemistry, hematology, coagulation, serology, or urinalysis at the screening or admission visit that is considered clinically significant by the investigator or meets grades 2-4 Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, or in the opinion of the investigator, could interfere with the objective of the study or the safety of the subject. Notwithstanding, the following values must remain within the normal range values (as determined by the Physician Reference Laboratory [PRL]) in order for a subject to be eligible for the study: calcium, magnesium, potassium, creatinine, ALT, AST, GGT, hemoglobin, absolute lymphocyte count, absolute 50 mg/dL in asymptomatic subjects and absolute leukocyte count values as low as 3.1x109/L in African American subjects will be considered for enrollment at the investigator's discretion. Lastly, the upper limit value for exclusion is modified for the following values and is as follows: INR>1.2, total bilirubin>1.2 mg/dL, serum amylase >143 U/L, LDH>261 U/L, and CPK>367 U/L, which do not normalize upon repeat testing, will be exclusionary.
- The subject has used one of the prohibited drugs, substances or foods as follows:
- any investigational product within 60 days (or 5 half-lives, whichever is longer) preceding the study
- any prescription or nonprescription medication (including herbal remedies, vitamins, or dietary supplements) or vaccine within 14 days of the first day of study drug administration (day 1) or within 5 half-lives before the first day of study drug administration, whichever is longer. Exceptions are locally acting medications (eg, topical creams), which are not allowed within 5 days of study drug administration, and the occasional use of acetaminophen (up to 3 g/day) and ibuprofen (up to 1200 mg/day).
- consumption of grapefruit, grapefruit juice, Seville oranges, pomelo-containing products, within the 14 days prior to day -1 and then throughout the entire study
- consumption of excessive amounts of alcoholic beverages, defined as more than 3 drinks per day (beer, wine, or distilled spirits), or unwillingness to comply with the restricted use of alcohol during the study (96 hours prior to admission and until 48 hours after the last study drug administration), history of alcoholism, or evidence of drug/chemical abuse
- positive urine drug (cocaine, amphetamines, barbiturates, opiates, phencyclidine, benzodiazepines, tetrahydrocannabinol), cotinine, or alcohol screen at the screening visit or admission
- consumption of quinine (eg, tonic water) within 7 days prior to admission
- The subject has any other condition, which, in the opinion of the investigator, makes the subject inappropriate for the study.
- Other exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Double-Blind, Randomized, Placebo- and Positive-Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Custirsen (640 mg) on Cardiac Repolarization in Healthy Men
This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized study, to compare treatment with intravenous custirsen at 640 mg (highest intended therapeutic dose) with placebo. The purpose of this study is to assess the effect of custirsen treatment on cardiac conduction and repolarization (electrical activity of the heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The moxifloxacin arm is un-blinded but the ECG readings are blinded.
Read the detailed description
The effects of custirsen will be evaluated following administration of a single dose following dose-titration period combined with dexamethasone pretreatment. On days -1 and 7, subjects will undergo a full ECG assessment for 24 hours. On day 1, randomization and assignment to the treatment groups will be performed prior to drug administration. Subjects will remain in the study center throughout the treatment period. All subjects will be discharged at the end of day 8 procedures, 24 hours after the last dose of custirsen has been administered. Subjects in groups 1 and 2 will return for an additional visit on day 9, 10 and 14 (±2 days) (approximately 7 days after the last study drug administration). Subjects in group 3 will not return for a follow-up visits.
- Conditions
- Cardiac Conduction and Repolarization
- Being tested
- Custirsen, Placebo, Moxifloxacin
- Keywords
- Custirsen sodium, TV1011, OGX-011, Thorough QT study, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CustirsenDrug
Also called custirsen sodium
Custirsen will be administered iv using an infusion pump over a 2-hour period.
PlaceboDrug
Also called Normal saline
Placebo (commercially available normal saline) will be administered iv using an infusion pump over a 2-hour period.
MoxifloxacinDrug
Moxifloxacin (400 mg) will be administered orally with 240 mL of room temperature still water.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: investigational product (custirsen) will receive:
* 320 mg of custirsen + 5 mg of dexamethasone on day 1
* 480 mg of custirsen + 5 mg of dexamethasone on day 3
* 640 mg of custirsen + 3 mg of dexamethasone on day 5
* 640 mg of custirsen on day 7 under fasting conditions Receives: Drug: Custirsen |
| Group 2 | Placebo comparator | Group 2: placebo (normal saline) will receive:
* placebo + 5 mg of dexamethasone on day 1
* placebo + 5 mg of dexamethasone on day 3
* placebo + 3 mg of dexamethasone on day 5
* placebo on day 7 under fasting conditions Receives: Drug: Placebo |
| Group 3 | Active comparator | Group 3: positive control (moxifloxacin) will receive:
* placebo + 5 mg of dexamethasone on day 1
* placebo + 5 mg of dexamethasone on day 3
* placebo + 3 mg of dexamethasone on day 5
* 400 mg of moxifloxacin + placebo (immediately after moxifloxacin administration) on day 7 under fasting conditions Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individually-corrected QT interval (QTcI)
The primary ECG variable and endpoint for this study is the time-matched change from baseline in QTcI method on day 7 at each time point. Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
Measured: Up to 23.5 hours after the start of study drug infusion on Day 7
Secondary outcomes (16)
Fridericia-corrected QT interval (QTcF)
QTcF time-matched change from baseline on day 7 at the following time points: 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours
Measured: Up to 23.5 hours after study drug infusion on Day 7
Heart rate, PR interval, QRS interval and uncorrected QT interval
Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
Measured: Up to 23.5 hours after study drug infusion on Day 7
ECG morphological patterns
Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
Measured: Up to 23.5 hours after study drug infusion on Day 7
QTc (QTcI and QTcF) Intervals
The relationship between the placebo-corrected QTc (QTcI and QTcF) change from baseline and plasma concentrations of custirsen (pharmacokinetic/pharmacodynamic analysis). Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
Measured: Up to 23.5 hours after study drug infusion on Day 7
Assay sensitivity
A comparison between the active control, moxifloxacin (400 mg), and placebo will also be performed to demonstrate assay sensitivity as required by current regulatory guidance. Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
Measured: Up to 23.5 hours after study drug infusion on Day 7
Maximum observed plasma concentration (Cmax)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Time to maximum observed plasma concentration (Tmax)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the plasma concentration-time curve (AUC0-t)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the curve from time 0 to infinity (AUC0-∞)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Percentage of AUC0-∞ due to extrapolation from the time of last measurable concentration to infinity
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the curve from time 0 to 24 hours (AUC0-24)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Terminal elimination rate constant (kel)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent terminal half life (t½)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent volume of distribution (Vz)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent total body clearance (CL)
Measured: From Day 1 through the Follow-up Visit (approximately Day 17)
Occurrence of Adverse Events
Measured: From signing of the informed consent through the Follow-up Visit (approximately 17 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Conduction and RepolarizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874561
- Sponsor's protocol ID
- TV1011-TQT-108
- Status last verified
- Oct 2016
- First submitted
- 1 May 2013
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Randomized, Placebo- and Positive-Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Custirsen (640 mg) on Cardiac Repolarization in Healthy Men
- ClinicalTrials.gov ID
- NCT01874561
- Acronym / sponsor ID
- TV1011-TQT-108
- Conditions
- Cardiac Conduction and Repolarization
- Keywords
- Custirsen sodium, TV1011, OGX-011, Thorough QT study, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jun 2013 (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 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized study, to compare treatment with intravenous custirsen at 640 mg (highest intended therapeutic dose) with placebo. The purpose of this study is to assess the effect of custirsen treatment on cardiac conduction and repolarization (electrical activity of the heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The moxifloxacin arm is un-blinded but the ECG readings are blinded.
Detailed description
The effects of custirsen will be evaluated following administration of a single dose following dose-titration period combined with dexamethasone pretreatment. On days -1 and 7, subjects will undergo a full ECG assessment for 24 hours. On day 1, randomization and assignment to the treatment groups will be performed prior to drug administration. Subjects will remain in the study center throughout the treatment period. All subjects will be discharged at the end of day 8 procedures, 24 hours after the last dose of custirsen has been administered. Subjects in groups 1 and 2 will return for an additional visit on day 9, 10 and 14 (±2 days) (approximately 7 days after the last study drug administration). Subjects in group 3 will not return for a follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CustirsenGroup 1: investigational product (custirsen) will receive: * 320 mg of custirsen + 5 mg of dexamethasone on day 1 * 480 mg of custirsen + 5 mg of dexamethasone on day 3 * 640 mg of custirsen + 3 mg of dexamethasone on day 5 * 640 mg of custirsen on day 7 under fasting conditions |
| Group 2 | Placebo comparator | Drug: PlaceboGroup 2: placebo (normal saline) will receive: * placebo + 5 mg of dexamethasone on day 1 * placebo + 5 mg of dexamethasone on day 3 * placebo + 3 mg of dexamethasone on day 5 * placebo on day 7 under fasting conditions |
| Group 3 | Active comparator | Drug: MoxifloxacinGroup 3: positive control (moxifloxacin) will receive: * placebo + 5 mg of dexamethasone on day 1 * placebo + 5 mg of dexamethasone on day 3 * placebo + 3 mg of dexamethasone on day 5 * 400 mg of moxifloxacin + placebo (immediately after moxifloxacin administration) on day 7 under fasting conditions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject is a man aged 18 through 45 years of age with a body mass index (BMI) of 18 through 30 kg/m2 at screening.
- The subject is in good health as determined by medical history, ECG, vital signs measurements, physical examination, and clinical laboratory tests.
- The subject must be able to understand and comply with the requirements of the study (eg, all medication, dietary, exercise, tobacco, and alcohol restrictions).
- The subject must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator or delegate.
- Other inclusion criteria apply.
Key exclusion criteria (21 listed)
- Exclusion criteria related to ECG findings include the following:
- Exclusion criteria related to cardiac function include the following:
- The subject has low serum potassium and/or magnesium and/or corrected calcium blood levels (less than 3.5 milliequivalent/liter (mEq/L), 1.8 mEq/L, and 8.9 mg/dL, respectively) at screening and/or day-2.
- The subject has any condition that may possibly interfere with drug absorption, distribution, metabolism, or excretion (eg, previous surgery on the gastrointestinal tract [including removal of parts of stomach, bowel, liver, gall bladder, or pancreas] or stomach banding).
- The subject has an abnormality in medical history, physical examination, biochemistry, hematology, coagulation, serology, or urinalysis at the screening or admission visit that is considered clinically significant by the investigator or meets grades 2-4 Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, or in the opinion of the investigator, could interfere with the objective of the study or the safety of the subject. Notwithstanding, the following values must remain within the normal range values (as determined by the Physician Reference Laboratory [PRL]) in order for a subject to be eligible for the study: calcium, magnesium, potassium, creatinine, ALT, AST, GGT, hemoglobin, absolute lymphocyte count, absolute 50 mg/dL in asymptomatic subjects and absolute leukocyte count values as low as 3.1x109/L in African American subjects will be considered for enrollment at the investigator's discretion. Lastly, the upper limit value for exclusion is modified for the following values and is as follows: INR>1.2, total bilirubin>1.2 mg/dL, serum amylase >143 U/L, LDH>261 U/L, and CPK>367 U/L, which do not normalize upon repeat testing, will be exclusionary.
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 |
|---|---|---|
| CustirsenAlso: custirsen sodiumCustirsen will be administered iv using an infusion pump over a 2-hour period. | Drug | Group 1 |
| PlaceboAlso: Normal salinePlacebo (commercially available normal saline) will be administered iv using an infusion pump over a 2-hour period. | Drug | Group 2 |
| MoxifloxacinMoxifloxacin (400 mg) will be administered orally with 240 mL of room temperature still water. | Drug | Group 3 |
Primary outcome
Individually-corrected QT interval (QTcI)
Time frame: Up to 23.5 hours after the start of study drug infusion on Day 7
The primary ECG variable and endpoint for this study is the time-matched change from baseline in QTcI method on day 7 at each time point. Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
16 secondary outcomes
Fridericia-corrected QT interval (QTcF)
Time frame: Up to 23.5 hours after study drug infusion on Day 7
Heart rate, PR interval, QRS interval and uncorrected QT interval
Time frame: Up to 23.5 hours after study drug infusion on Day 7
ECG morphological patterns
Time frame: Up to 23.5 hours after study drug infusion on Day 7
QTc (QTcI and QTcF) Intervals
Time frame: Up to 23.5 hours after study drug infusion on Day 7
Assay sensitivity
Time frame: Up to 23.5 hours after study drug infusion on Day 7
Maximum observed plasma concentration (Cmax)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Time to maximum observed plasma concentration (Tmax)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the plasma concentration-time curve (AUC0-t)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the curve from time 0 to infinity (AUC0-∞)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Percentage of AUC0-∞ due to extrapolation from the time of last measurable concentration to infinity
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Area under the curve from time 0 to 24 hours (AUC0-24)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Terminal elimination rate constant (kel)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent terminal half life (t½)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent volume of distribution (Vz)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Apparent total body clearance (CL)
Time frame: From Day 1 through the Follow-up Visit (approximately Day 17)
Occurrence of Adverse Events
Time frame: From signing of the informed consent through the Follow-up Visit (approximately 17 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 10 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Custirsen and Moxifloxacin in people with Cardiac Conduction and Repolarization, run by Achieve Life Sciences 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 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. 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?
Individually-corrected QT interval (QTcI) (time frame: Up to 23.5 hours after the start of study drug infusion on Day 7). 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 10 Oct 2016.