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

Tolerability Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121302
• Other study ID #: D3030C00001
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2010
• Last updated: January 27, 2015
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tolerability

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213		Frequent timepoints within 48 hours of single dose administration	No
Secondary	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.	No

External Links

•   D3030C00001 Clinical Study Report Synopsis