AZD7325 Multiple Ascending Dose Study

Healthy Volunteer Clinical Trial

— MAD  

Official title:

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681915
• Other study ID #: D1140C00002
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2008
• Last updated: December 7, 2010
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD7325
Oral

Locations

Country	Name	City	State
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses		Blood samples will be taken during the study.	No
Secondary	Evaluation of the pharmacodynamic effects of AZD7325		Test batteries will be performed at specified times both before and following study drug administration.	No
Secondary	Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.		A single blood sample will be obtained.	No