AZD3293 Thorough QT Study in Healthy Male Volunteers
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- 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
- ...
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- 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
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Exclusion Criteria
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- 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 neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- 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 psychotic disorder among first degree relatives
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
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
- 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
- ...
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- 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
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Exclusion Criteria
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- 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 neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- 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 psychotic disorder among first degree relatives
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
Tracking Information
- NCT #
- NCT02040987
- Collaborators
- Parexel
- Investigators
- Principal Investigator: Ronald Goldwater, MD Parexel ECPU Baltimore
- Ronald Goldwater, MD Parexel ECPU Baltimore
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