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Completed

NCT Number: NCT02040987

AZD3293 Thorough QT Study in Healthy Male Volunteers

A thorough QT study of AZD3293

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Baltimore, Maryland, United States

About this study

A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed, written and dated informed consent prior to any study-specific procedures
  • Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
  • Healthy male subjects aged 18 to 55 years
  • Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
  • Clinically normal findings on physical examination in relation to age, as judged by the investigator.

Exclusion criteria

  • History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
  • History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
  • History of psychotic disorder among first degree relatives

Treatment and study plan

AZD3293

Drug

AZD3293 oral solution - one single dose (low dose).

Other names: beta secretase inhibitor

Placebo

Drug

Placebo oral solution - one single dose

moxifloxacin

Drug

Moxifloxacin tablet - one single dose

Primary outcomes

  1. The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.

    Time frame: Up to 69 days

    The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula

Secondary outcomes

  1. The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.

    Time frame: Up to 69 days

    The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.

  2. The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures

    Time frame: Up to 69 days

    Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables

  3. Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects

    Time frame: Up to 69 days

    AUC(0-t): Area under the concentration versus time curve from time 0 to the time of the last quantifiable concentration to be calculated by a combination of linear and logarithmic trapezoidal methods (linear up-log down) Cmax: Maximum observed plasma concentration obtained directly from the concentration vs. time data tmax: Time to reach Cmax following dose, obtained directly from the concentration vs. time data

  4. The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)

    Time frame: Up to 69 days

    RR: The time between corresponding points on 2 consecutive R waves on ECG. PR: ECG interval measured from the onset of the P wave to the onset of the QRS complex. QRS: ECG interval measured from the onset of the QRS complex to the J point. QT: ECG interval measured from the onset of the QRS complex to the offset of the T wave. QTcB: The heart rate corrected QT calculated using Bazett's formula.

Other outcomes

  1. The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters

    Time frame: Up to 69 days

    The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects

Acronym: AZD3293TQT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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