AZD7325 Multiple Ascending Dose Study

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD7325

• Registration Number: NCT00681915
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD7325	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs	Alssessments are made at each visit, at least daily, during the study.

Secondary Outcome Measures

Name	Time	Method
Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses	Blood samples will be taken during the study.
Evaluation of the pharmacodynamic effects of AZD7325	Test batteries will be performed at specified times both before and following study drug administration.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.	A single blood sample will be obtained.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States