NCT02040987

Brief Summary

A thorough QT study of AZD3293

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

January 17, 2014

Last Update Submit

July 2, 2014

Conditions

Alzheimer's Disease

Keywords

Thorough QT study

Outcome Measures

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.

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

    Up to 69 days

Secondary Outcomes (4)

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

    Up to 69 days

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

    Up to 69 days

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

    Up to 69 days

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

    Up to 69 days

Other Outcomes (1)

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

    Up to 69 days

Study Arms (4)

AZD3293 dose A

EXPERIMENTAL

AZD3293 therapeutic dose oral solution (low dose)

Drug: AZD3293

AZD3293 dose B

EXPERIMENTAL

AZD3293 supratherapeutic dose oral solution (high dose)

Drug: AZD3293

Placebo

PLACEBO COMPARATOR

Placebo oral solution

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin tablet

Drug: Moxifloxacin

Interventions

AZD3293DRUG

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

Also known as: beta secretase inhibitor
AZD3293 dose A
PlaceboDRUG

Placebo oral solution - one single dose

Placebo
MoxifloxacinDRUG

Moxifloxacin tablet - one single dose

Moxifloxacin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lanabecestatMoxifloxacin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ronald Goldwater, MD

    Parexel ECPU Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

US(1)