Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Tolerability

Treatments

Drug: AZD5213

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01121302

D3030C00001

Details and patient eligibility

About

The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.

One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.

Enrollment

88 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastorintestinal 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.