AZD7325 Multiple Ascending Dose Study (MAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: AZD7325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681915

D1140C00002

Details and patient eligibility

About

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects must be of non-child bearing potential.

Exclusion criteria

• Clinically significant illness within 2 weeks before the study start.
• Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
• Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
• Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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48 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD7325