Recruitment

Recruitment Status
Completed

Inclusion Criteria

Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
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
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
Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Provision of signed, written and dated informed consent prior to any study-specific procedures

Exclusion Criteria

History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
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 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 psychotic disorder among first degree relatives
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

Summary

Conditions
Alzheimer's Disease
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

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

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

Inclusion Criteria

Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
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
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
Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Provision of signed, written and dated informed consent prior to any study-specific procedures

Exclusion Criteria

History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
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 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 psychotic disorder among first degree relatives
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

Tracking Information

NCT #
NCT02040987
Collaborators
Parexel
Investigators
  • Principal Investigator: Ronald Goldwater, MD Parexel ECPU Baltimore
  • Ronald Goldwater, MD Parexel ECPU Baltimore