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

Phase 1

Completed

• Conditions: Tolerability
• Interventions: Drug: Placebo; Drug: AZD5213

• Registration Number: NCT01121302
• Lead Sponsor: AstraZeneca

Brief Summary

1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses.

2. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Placebo	placebo
1	AZD5213	dose escalating

Primary Outcome Measures

Name	Time	Method
Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale	AE will be collected from admission on Day -1 until follow-up

Secondary Outcome Measures

Name	Time	Method
Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213	Frequent timepoints within 48 hours of single dose administration
Part 2 Investigate the potential effect of food on AZD5213 PK after administration of AZD5213 as an oral solution	Frequent timepoints after volunteer consumes a high fat, high calorie breakfast, per FDA guidelines.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States