AZD3293 Thorough QT Study in Healthy Male Volunteers

Alzheimer's Disease Clinical Trial

— AZD3293TQT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040987
• Other study ID #: D5010C00008
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2014
• Last updated: July 2, 2014
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A thorough QT study of AZD3293

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Provision of signed, written and dated informed consent prior to any study-specific procedures

2. Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

3. Healthy male subjects aged 18 to 55 years

4. Body weight = 50 to = 100 kg and body mass index (BMI) =19 to =30

5. Clinically normal findings on physical examination in relation to age, as judged by the investigator.

Exclusion Criteria:

1. 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

2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

3. History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder

4. History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury

5. History of psychotic disorder among first degree relatives

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AZD3293
AZD3293 oral solution - one single dose (low dose).
• AZD3293
AZD3293 oral solution - one single dose (high dose).
• Placebo
Placebo oral solution - one single dose
• Moxifloxacin
Moxifloxacin tablet - one single dose

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters	The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula	Up to 69 days	Yes
Primary	The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.	The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula	Up to 69 days	Yes
Secondary	The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.	The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.	Up to 69 days	Yes
Secondary	The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures	Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables	Up to 69 days	Yes
Secondary	Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects	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	Up to 69 days	Yes
Secondary	The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)	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.	Up to 69 days	Yes