A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935662

Enrollment

119

Registered

2009-07-09

Start date

2009-07-31

Completion date

2010-08-31

Last updated

2010-09-13

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

Conditions

Healthy Men

Keywords

First time in man, Safety study, AZD8329

Brief summary

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Interventions

DRUGPlacebo

Oral solution, placebo

DRUGAZD8329

Oral solution, single ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of informed consent prior to any study specific procedures * Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion criteria

* 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 result of the study, or the subject´s ability to participate * Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Design outcomes

Primary

Measure	Time frame
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

Secondary

Measure	Time frame
PK samples for AZD8329	Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.

Countries

Sweden

Outcome results

None listed

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