AZD8529 Single Ascending Dose Study (SAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: AZD8529

Study type: Interventional

Funder types: Industry

Identifiers

NCT00755378

D1960C00001

Details and patient eligibility

About

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

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

58 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD8529

2

Placebo Comparator group

Treatment:

Drug: Placebo