AZD3293 Thorough QT Study in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

A thorough QT study of AZD3293

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pharmaceutical Solutions

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