Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

AZD3293 Thorough QT Study in Healthy Male Volunteers (AZD3293TQT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02040987
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A thorough QT study of AZD3293

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: AZD3293 Drug: Placebo Drug: Moxifloxacin Phase 1

Detailed 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : January 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: AZD3293 dose A
AZD3293 therapeutic dose oral solution (low dose)
Drug: AZD3293
AZD3293 oral solution - one single dose (low dose).
Other Name: beta secretase inhibitor

Experimental: AZD3293 dose B
AZD3293 supratherapeutic dose oral solution (high dose)
Drug: AZD3293
AZD3293 oral solution - one single dose (high dose).

Placebo Comparator: Placebo
Placebo oral solution
Drug: Placebo
Placebo oral solution - one single dose

Active Comparator: Moxifloxacin
Moxifloxacin tablet
Drug: Moxifloxacin
Moxifloxacin tablet - one single dose




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040987


Locations
Layout table for location information
United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Parexel
Investigators
Layout table for investigator information
Principal Investigator: Ronald Goldwater, MD Parexel ECPU Baltimore

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02040987     History of Changes
Other Study ID Numbers: D5010C00008
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by AstraZeneca:
Thorough QT study

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs