AZD7325 Japan Multiple Ascending Dose (MAD) Study

Healthy Clinical Trial

— JMAD  

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 Japanese Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945425
• Other study ID #: D1140C00015
• Status: Terminated
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: February 15, 2011
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Japanese subjects

Exclusion Criteria:

• Significant illness, as judged by the investigator, within 2 weeks of Day 1

• Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit

• Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1

• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD7325
oral capsule, once or twice daily, 7 days
• Placebo
oral capsule, once or twice daily, 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

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 in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.		Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).	Yes
Secondary	To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.		Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).	No
Secondary	To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).		Observations/Assessments are made during the treatment visit.	No