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Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects (TQT)

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ClinicalTrials.gov Identifier: NCT01487135
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : October 10, 2014
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE December 7, 2011
Last Update Posted Date October 10, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01487135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
  • Change-from-baseline in individual corrected QTc (ΔQTcI) for positive control vs. placebo [ Time Frame: Day 1: predose to 20 hours postdose ]
    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.
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects
Official Title  ICMJE 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.
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Subjects
  • Cardiac Repolarization
Intervention  ICMJE
  • Drug: EVP-6124
    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.
  • Drug: Placebo
    Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.
  • Drug: Moxifloxacin
    A moxifloxacin 400 mg tablet administered orally on Day 1
    Other Name: Avelox
Study Arms  ICMJE
  • Experimental: EVP-6124
    A single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo
    Cranberry juice (180 mL)
    Intervention: Drug: EVP-6124
  • Active Comparator: Moxifloxacin
    A single dose of 400-mg Moxifloxacin
    Intervention: Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01487135
Other Study ID Numbers  ICMJE EVP-6124-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FORUM Pharmaceuticals Inc
Study Sponsor  ICMJE FORUM Pharmaceuticals Inc
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE Not Provided
PRS Account FORUM Pharmaceuticals Inc
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP