HealthyPhase 1NCT01790087
ANX-188 Thorough QT/QTc Study in Healthy Volunteers
A Phase 1 study testing ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose and Saline in people with Healthy, run by Mast Therapeutics, Inc. at 1 site in United States.
Trial summary
This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose and Saline
- 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening.
Who cannot join
- Participation in a clinical trial within the last 60 days
- Pregnant or lactating females
- Use of prescription drugs, herbals, or over-the-counter medications within 14 days prior to study day -2
- Uncontrolled cardiac arrhythmias, cardiac valve abnormalities, or not in normal sinus rhythm
- Smokers or tobacco product user in the prior 3 months
- Presence of clinically significant illness
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Four Period, Four-Arm, Crossover Design, Randomized, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Single-Dose ANX-188 on the QT/QTc Intervals in Healthy Volunteers
This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)
- Conditions
- Healthy
- Being tested
- ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose, Saline, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX-188 Therapeutic DoseDrug
Also called vepoloxamer
ANX-188 Supratherapeutic doseDrug
Also called vepoloxamer
SalineDrug
Also called Placebo Comparator
MoxifloxacinDrug
Also called Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| ANX-188 Therapeutic dose level | Experimental | IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours Receives: Drug: ANX-188 Therapeutic Dose |
| ANX-188 Supratherapeutic dose | Experimental | IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours Receives: Drug: ANX-188 Supratherapeutic dose |
| Saline | Placebo comparator | IV administration. Six hour infusion. Receives: Drug: Saline |
| Moxifloxacin | Active comparator | Oral tablet. 400 mg. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
Measured: Day 1 Pre-dose to 24 hours post-dose
Secondary outcomes (11)
Bazett's corrected QT-interval (QTcB)
Measured: Pre-dose to 24 hours post-dose
Heart rate measurements on treatment compared to time-matched baseline and placebo
Measured: Pre-dose to 24 hours post-dose
RR-interval on treatment compared to time-matched baseline and placebo
Measured: Pre-dose to 24 hours post-dose
QRS measurements on treatment compared to time-matched baseline and placebo
Measured: Pre-dose to 24 hours post-dose
PR interval measurements on treatment compared to time-matched baseline and placebo
Measured: Pre-dose to 24 hours post-dose
Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs
Measured: Pre-dose to 24 hours post-dose
Number and percentage of subjects that develop abnormalities of repolarization on treatment
Measured: Pre-dose to 24 hours post-dose
Number and percentage of subjects the develop abnormal U waves
Measured: Pre-dose to 24 hours post-dose
Relationship between changes from the baseline and placebo in QTcF (DDQTcF)
Measured: Pre-dose to 24 hours post-dose
Analysis for arrhythmias
Measured: Pre-dose to 24 hours post-dsoe
Correlation of ECG findings with clinical adverse events
Measured: Pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionJun 2013
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin L Parsley, D.O., Study director, Mast Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790087
- Sponsor's protocol ID
- ANX-188-05
- Status last verified
- May 2015
- First submitted
- 11 Feb 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Period, Four-Arm, Crossover Design, Randomized, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Single-Dose ANX-188 on the QT/QTc Intervals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01790087
- Acronym / sponsor ID
- ANX-188-05
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Feb 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 study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ANX-188 Therapeutic dose level | Experimental | Drug: ANX-188 Therapeutic DoseIV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours |
| ANX-188 Supratherapeutic dose | Experimental | Drug: ANX-188 Supratherapeutic doseIV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours |
| Saline | Placebo comparator | Drug: SalineIV administration. Six hour infusion. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinOral tablet. 400 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening.
Key exclusion criteria (7 listed)
- Participation in a clinical trial within the last 60 days
- Pregnant or lactating females
- Use of prescription drugs, herbals, or over-the-counter medications within 14 days prior to study day -2
- Uncontrolled cardiac arrhythmias, cardiac valve abnormalities, or not in normal sinus rhythm
- Smokers or tobacco product user in the prior 3 months
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 |
|---|---|---|
| ANX-188 Therapeutic DoseAlso: vepoloxamer | Drug | ANX-188 Therapeutic dose level |
| ANX-188 Supratherapeutic doseAlso: vepoloxamer | Drug | ANX-188 Supratherapeutic dose |
| SalineAlso: Placebo Comparator | Drug | Saline |
| MoxifloxacinAlso: Active Comparator | Drug | Moxifloxacin |
Primary outcome
Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
Time frame: Day 1 Pre-dose to 24 hours post-dose
11 secondary outcomes
Bazett's corrected QT-interval (QTcB)
Time frame: Pre-dose to 24 hours post-dose
Heart rate measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
RR-interval on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
QRS measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
PR interval measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs
Time frame: Pre-dose to 24 hours post-dose
Number and percentage of subjects that develop abnormalities of repolarization on treatment
Time frame: Pre-dose to 24 hours post-dose
Number and percentage of subjects the develop abnormal U waves
Time frame: Pre-dose to 24 hours post-dose
Relationship between changes from the baseline and placebo in QTcF (DDQTcF)
Time frame: Pre-dose to 24 hours post-dose
Analysis for arrhythmias
Time frame: Pre-dose to 24 hours post-dsoe
Correlation of ECG findings with clinical adverse events
Time frame: Pre-dose to 24 hours 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 20 May 2015.
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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.
Edwin L Parsley, D.O. study director
Mast Therapeutics
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 ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose and Saline in people with Healthy, run by Mast Therapeutics, Inc. 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 1 inclusion and 7 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 20 May 2015. 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?
Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF) (time frame: Day 1 Pre-dose to 24 hours 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 20 May 2015.