AZD8529 Single Ascending Dose Study

Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755378

Acronym

SAD

Enrollment

Registered

2008-09-19

Start date

2008-09-30

Completion date

2009-03-31

Last updated

2009-03-26

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

Conditions

Healthy Volunteer

Keywords

Phase I

Brief summary

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses

Interventions

DRUGAZD8529

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.

Exclusion criteria

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod * Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.	at each visit, at least daily, during the study.

Secondary

Measure	Time frame
To characterize the pharmacokinetics of AZD8529 in plasma and urine.	Blood and urine samples will be taken during the study.
To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.	Safety assessments and blood and urine samples will be taken throughout the study.

Countries

United States

Outcome results

None listed

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