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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121302

Enrollment

Registered

2010-05-12

Start date

2010-05-31

Completion date

2010-12-31

Last updated

2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tolerability

Keywords

AZD5213, Phase 1, Safety

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.

Interventions

DRUGAZD5213

0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

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

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026