Healthy SubjectsPhase 1TQTNCT01487135
Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects
A Phase 1 study testing EVP-6124 and Moxifloxacin in people with Healthy Subjects and Cardiac Repolarization, run by FORUM Pharmaceuticals Inc.
Trial summary
The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and supratherapeutic concentrations on cardiac repolarization in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Cardiac Repolarization
- What is being tested?
- EVP-6124 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc for 60 days prior to the administration of the study medication)
- Physically and mentally healthy volunteers
Who cannot join
- Clinically significant electrocardiographic abnormality in the opinion of the Investigator
- History of cardiovascular abnormalities/conditions including syncope in the 3 months preceding enrollment or any history of significant previous cardiac arrhythmia;
- Potassium levels outside of the normal ranges (3.5 to 5.2 mEq/L)
- Clinically significant deviations from normal blood pressure (BP) as judged by the Investigator
- Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the Investigator
- Unwilling to refrain from strenuous exercise from 3 days prior to baseline Day -1 through discharge of each treatment period
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- Family history of Torsade de Pointes or long-QT syndrome, or cardiac death or sudden death without a preceding diagnosis of a condition that could be causative of sudden death
- Evidence of any chronic medical condition requiring prescription medications
- History of study drug allergy (including moxifloxacin, likely hypersensitivity or allergies to EVP-6124, or any components of EVP-6124)
- Current or history of drug or alcohol abuse within the past year
- Abnormal preadmission clinical laboratory evaluations which are considered clinically significant by the Principal Investigator
- Any subject considering or scheduled to undergo any surgical procedure during the study
- Acute illness within 7 days prior to study agent administration or have had a major illness or hospitalization within 1 month prior to study agent administration
- Any subject who has received any known hepatic or renal clearance altering agents within 30 days prior to the first dose of study drug
- A positive serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody at screening
- A positive urine drug screen for ethanol or substances of abuse including cocaine,cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone at check-in(s)
- Female subjects of childbearing potential with positive serum pregnancy test at screening or baseline (Day -1) of each treatment period. Sexually active females who refuse to take appropriate steps not to become pregnant during the course of the clinical study
- Men, sexually active with female partners of childbearing potential, who are unwilling to use appropriate contraception during the course of the study and for 30 days after discharge from the last treatment period
- Donated plasma or blood within 30 days prior to the first dose of study medication or has a history of blood donation of more than 450 mL within 3 months prior to dosing
- Use of any prescription medications/products, within 14 days prior to dose administration on Day 1 of Treatment Period 1, unless deemed acceptable by the Investigator
- Use of any over-the-counter, nonprescription preparations (including minerals, and phytotherapeutic/herbal/plant-derived preparations), within 14 days prior to dose administration on Day 1 of Treatment Period 1, with the exception of acetaminophen used at recommended doses
- Use of investigational drug 30 days prior to Day -1 of Treatment Period 1
About this study
Official title: A Randomized, Double-blind, Placebo- and Active-controlled, 3-way Crossover, Phase 1 Study to Evaluate the Effect of EVP-6124 at Therapeutic and Supratherapeutic Concentrations Following a 2-dose EVP-6124 Regimen on the QT Interval in Healthy Male and Female Subjects.
The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and supratherapeutic concentrations on cardiac repolarization in healthy subjects.
Read the detailed description
Subjects will be randomized to six treatment sequences of 10 subjects each. Subjects will be admitted to the clinic on Day -1 before dosing. Each of the EVP-6124 and placebo treatment periods (blinded) will include a 10-day/9-night confinement to the Clinical Pharmacology Unit (CPU) with study drugs being administered on Day 1 and Day 2. The moxifloxacin treatment period (open-label) will include a 3-day/2-night confinement to the CPU with moxifloxacin administration on Day 1.
The study will include 2 washout periods in which each washout starts from the time of the last dose of the preceding treatment period to the first dose of the next treatment period. The washouts following the EVP-6124 or placebo treatments will be 30 days while the washout following the moxifloxacin treatment will be 7 days. Follow-up visit (5 to 10 days following discharge from the CPU).
- Conditions
- Healthy Subjects, Cardiac Repolarization
- Being tested
- EVP-6124, Placebo, Moxifloxacin
- Keywords
- Thorough QT (TQT), EVP-6124
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVP-6124Drug
A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1 and a high dose of EVP-6124 in cranberry juice (180 mL) administered on Day 2.
PlaceboDrug
Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.
MoxifloxacinDrug
Also called Avelox
A moxifloxacin 400 mg tablet administered orally on Day 1
| Study group | Role | What they receive |
|---|---|---|
| EVP-6124 | Experimental | A single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124 Receives: Drug: Placebo |
| Placebo | Placebo comparator | Cranberry juice (180 mL) Receives: Drug: EVP-6124 |
| Moxifloxacin | Active comparator | A single dose of 400-mg Moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change-from-baseline in individual corrected QTc (ΔQTcI) for EVP-6124 vs. placebo
Change-from-baseline in Fridericia's correction QTc (ΔQTcF) and change-from-baseline in Bazett's correction QTc (ΔQTcB) will be secondary variables.
The placebo-corrected baseline-adjusted QTc (ΔΔQTc), calculated as differences between time-matched mean change-from-baseline QTc values obtained on Day 1 (low dose) and on Day 2 (high dose) of the EVP-6124 treatment relative to the corresponding QTc values obtained on Day 1 and Day 2 of the placebo treatment, will be evaluated to quantify the effect of EVP-6124 on cardiac repolarization.
Measured: Day 1: predose to 20 hours postdose; Day 2 predose to 168 hours postdose
Secondary outcomes (2)
Change-from-baseline in individual corrected QTc (ΔQTcI) for positive control vs. placebo
The placebo-corrected baseline-adjusted QTc (ΔΔQTc), calculated as differences between time-matched mean change-from-baseline QTc values obtained on Day 1 of the moxifloxacin treatment relative to QTc values obtained on Day 1 of the placebo treatment, will be evaluated to establish assay sensitivity.
Measured: Day 1: predose to 20 hours postdose
Safety and tolerability of EVP-6124 at low dose and high doses
All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements.
Measured: Day -1 through follow-up (5 to 10 days after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionSep 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORUM Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487135
- Sponsor's protocol ID
- EVP-6124-012
- Acronym
- TQT
- Status last verified
- Oct 2013
- First submitted
- 29 Nov 2011
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Active-controlled, 3-way Crossover, Phase 1 Study to Evaluate the Effect of EVP-6124 at Therapeutic and Supratherapeutic Concentrations Following a 2-dose EVP-6124 Regimen on the QT Interval in Healthy Male and Female Subjects.
- ClinicalTrials.gov ID
- NCT01487135
- Acronym / sponsor ID
- TQT / EVP-6124-012
- Conditions
- Healthy Subjects, Cardiac Repolarization
- Keywords
- Thorough QT (TQT), EVP-6124
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- FORUM Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Dec 2011 (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 purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and supratherapeutic concentrations on cardiac repolarization in healthy subjects.
Detailed description
Subjects will be randomized to six treatment sequences of 10 subjects each. Subjects will be admitted to the clinic on Day -1 before dosing. Each of the EVP-6124 and placebo treatment periods (blinded) will include a 10-day/9-night confinement to the Clinical Pharmacology Unit (CPU) with study drugs being administered on Day 1 and Day 2. The moxifloxacin treatment period (open-label) will include a 3-day/2-night confinement to the CPU with moxifloxacin administration on Day 1.
The study will include 2 washout periods in which each washout starts from the time of the last dose of the preceding treatment period to the first dose of the next treatment period. The washouts following the EVP-6124 or placebo treatments will be 30 days while the washout following the moxifloxacin treatment will be 7 days. Follow-up visit (5 to 10 days following discharge from the CPU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVP-6124 | Experimental | Drug: PlaceboA single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124 |
| Placebo | Placebo comparator | Drug: EVP-6124Cranberry juice (180 mL) |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinA single dose of 400-mg Moxifloxacin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonsmokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc for 60 days prior to the administration of the study medication)
- Physically and mentally healthy volunteers
Key exclusion criteria (22 listed)
- Clinically significant electrocardiographic abnormality in the opinion of the Investigator
- History of cardiovascular abnormalities/conditions including syncope in the 3 months preceding enrollment or any history of significant previous cardiac arrhythmia;
- Potassium levels outside of the normal ranges (3.5 to 5.2 mEq/L)
- Clinically significant deviations from normal blood pressure (BP) as judged by the Investigator
- Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the Investigator
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 |
|---|---|---|
| EVP-6124A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1 and a high dose of EVP-6124 in cranberry juice (180 mL) administered on Day 2. | Drug | Placebo |
| PlaceboCranberry juice only (180 mL) administered orally on both Day 1 and Day 2. | Drug | EVP-6124 |
| MoxifloxacinAlso: AveloxA moxifloxacin 400 mg tablet administered orally on Day 1 | Drug | Moxifloxacin |
Primary outcome
Change-from-baseline in individual corrected QTc (ΔQTcI) for EVP-6124 vs. placebo
Time frame: Day 1: predose to 20 hours postdose; Day 2 predose to 168 hours postdose
Change-from-baseline in Fridericia's correction QTc (ΔQTcF) and change-from-baseline in Bazett's correction QTc (ΔQTcB) will be secondary variables. The placebo-corrected baseline-adjusted QTc (ΔΔQTc), calculated as differences between time-matched mean change-from-baseline QTc values obtained on Day 1 (low dose) and on Day 2 (high dose) of the EVP-6124 treatment relative to the corresponding QTc values obtained on Day 1 and Day 2 of the placebo treatment, will be evaluated to quantify the effect of EVP-6124 on cardiac repolarization.
2 secondary outcomes
Change-from-baseline in individual corrected QTc (ΔQTcI) for positive control vs. placebo
Time frame: Day 1: predose to 20 hours postdose
Safety and tolerability of EVP-6124 at low dose and high doses
Time frame: Day -1 through follow-up (5 to 10 days after discharge)
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 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVP-6124 and Moxifloxacin in people with Healthy Subjects and Cardiac Repolarization, run by FORUM Pharmaceuticals Inc.
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 2 inclusion and 22 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 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change-from-baseline in individual corrected QTc (ΔQTcI) for EVP-6124 vs. placebo (time frame: Day 1: predose to 20 hours postdose; Day 2 predose to 168 hours postdose). 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 2014.