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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01171105

Enrollment

Registered

2010-07-28

Start date

2010-07-31

Completion date

2011-05-31

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

Healthy

Keywords

AZD5213 Phase 1, Safety, tolerability

Brief summary

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.

Interventions

DRUGAZD5213

oral solution, multiple ascending doses

DRUGPlacebo to AZD5213

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

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	Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose

Secondary

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.

Countries

United States

Outcome results

None listed

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