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

A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)

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.

Study Overview

• Status: Completed
• Conditions: Tolerability
• Intervention / Treatment: Drug: Placebo; Drug: AZD5213

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; placebo	Drug: Placebo
Experimental: 1; dose escalating	Drug: AZD5213; 0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: David Mathews, MD, Quintiles, Inc.

Publications and helpful links

Helpful Links

• D3030C00001 Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Phase 1; AZD5213
• Other Study ID Numbers: D3030C00001