Status:
COMPLETED
Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses. 2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - ...
Eligibility Criteria
Inclusion
- Male and non-fertile female healthy volunteers aged 18-50 years and 65-80 years inclusive at day of enrollment with suitable veins for cannulation or repeated venipuncture.
- Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD5213.
- Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.
Exclusion
- History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disorders.
- History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
- History of previous or ongoing psychiatric disorders.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01171105
Start Date
July 1 2010
End Date
May 1 2011
Last Update
January 28 2015
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States