Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940212

Acronym

SAD

Enrollment

Registered

2009-07-15

Start date

2009-07-31

Completion date

2009-11-30

Last updated

2010-12-10

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

Conditions

Healthy Volunteers

Keywords

Safety, tolerability, healthy, pharmacokinetics

Brief summary

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Interventions

DRUGAZD2423

oral, single administration

DRUGPlacebo

oral administration and single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures * Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg * Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.	3 day residential period plus 7-10 days follow up

Secondary

Measure	Time frame
To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.	3 day residential period plus 7-10 days follow up

Countries

Germany

Outcome results

None listed

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