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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121302
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : January 28, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tolerability Drug: AZD5213 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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

Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. 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 [ Time Frame: AE will be collected from admission on Day -1 until follow-up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121302

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Principal Investigator: David Mathews, MD Quintiles, Inc.

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01121302     History of Changes
Other Study ID Numbers: D3030C00001
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by AstraZeneca:
Phase 1