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A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers

NCT03258515 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-02-20

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, double-blind, 3-way crossover phase I study being conducted on healthy volunteers to investigate the effect of single dose of AZD6094 (600 mg) on cardiac repolarization under well-controlled conditions in accordance with the International Council for Harmonization (ICH) E14 guidelines. An open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a appositive control for the time between the start of the Q wave and the end of the T wave (QT) prolongation in accordance with ICH E14 guidelines, to establish assay sensitivity. The core study consists of screening period, 3 treatment period (AZD6094, placebo and moxifloxacin; with a minimum washout period of 14 days between each treatment period) and follow-up. The study drugs will be administered orally. The study is planned to determine effect of AZD6094 at therapeutic dose, safety and tolerability. This study provides adequate and well-controlled mechanisms to deal with potential bias, facilitate identification of effects related to investigational product (IMP) administration and tolerability issues.

Conditions

Interventions

DRUG

AZD6094 200 mg

A potent and selective small molecule mesenchymal epithelial transition (MET) kinase inhibitor with significant antitumor activity.

OTHER

Placebo

AZD6094 matching placebo without any pharmacological activity.

DRUG

Moxifloxacin

A fluoroquinolone broad-spectrum antibiotic, produces a mild, but reproducible increase in QT interval corrected (QTc) in healthy normal participants at time to reach maximum concentration (tmax - approximately 2 hours (0.5 to 4 hours)). This effect is close to the ECG interval measured from the onset of the QRS complex (onset of the QRS complex to the J point) to the offset of the T wave (QT)/QTc effect that represents the threshold of regulatory concern, around 5 ms mean QTc interval prolongation.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater, MD · PAREXEL Early Phase Clinical Unit Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-03-24
Completion
2018-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258515 on ClinicalTrials.gov