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

A Phase I, Double-blind, Randomized, Placebo-controlled', Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD5213 After Administration of Multiple Ascending Doses for 10 Days in Healthy Male and Non-fertile Female Volunteers

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 - 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 73
• 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 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo to AZD5213
Experimental: 1; AZD5213 (dose escalating)	Drug: AZD5213; oral solution, multiple 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	Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Multiple-dose PK and dose proportionality	Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
Time to reach steady state	Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
Degree of accumulation and time dependancy of orally-administered AZD5213	Frequent timepoints within 48 hours of multiple dose day 1 and day 12.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: David Mathews, MD, Quintiles, 6700 W. 115th Street, Overland Park, KS 66211

Publications and helpful links

Helpful Links

• D3030C00002 Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 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; tolerability; AZD5213 Phase 1
• Other Study ID Numbers: D3030C00002