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

NCT01487135 | Completed Phase 1

• 1 other identifier: EVP-6124-012
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects; Cardiac Repolarization

Keywords

Thorough QT (TQT); EVP-6124

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 1: predose to 20 hours postdose

• Safety and tolerability of EVP-6124 at low dose and high doses

  Day -1 through follow-up (5 to 10 days after discharge)

Study Arms (3)

EVP-6124

EXPERIMENTAL

A single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124

Drug: Placebo

Placebo

PLACEBO COMPARATOR

Cranberry juice (180 mL)

Drug: EVP-6124

Moxifloxacin

ACTIVE COMPARATOR

A single dose of 400-mg Moxifloxacin

Drug: Moxifloxacin

Interventions

EVP-6124 DRUG

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.

Placebo

Placebo DRUG

Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.

EVP-6124

Moxifloxacin DRUG

A moxifloxacin 400 mg tablet administered orally on Day 1

Also known as: Avelox

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc: lead
• Quintiles, Inc.: collaborator

MeSH Terms

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 10, 2014

Record last verified: 2013-10