AZD7325 Japan Multiple Ascending Dose (MAD) Study (JMAD)

This study has been terminated.

(Decided to stop development of this compound globally)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00945425

First received: July 23, 2009

Last updated: February 15, 2011

Last verified: February 2011

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD7325 Drug: Placebo	Phase 1

Study Type:	Interventional
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
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine. [ Time Frame: Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose). ] [ Designated as safety issue: No ]
To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition). [ Time Frame: Observations/Assessments are made during the treatment visit. ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
Experimental: 1 Low dose or placebo, twice daily	Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days
Experimental: 2 Low dose or placebo, once daily	Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days
Experimental: 3 Middle dose or placebo, twice daily	Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days
Experimental: 4 High dose or placebo, once daily	Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945425

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Yuji Kumagai, MD, PhD

Kitasato University East Hospital, Kanagawa, Japan

More Information

No publications provided

Responsible Party:	Raj Tummala, MD-Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00945425 History of Changes
Other Study ID Numbers:	D1140C00015
Study First Received:	July 23, 2009
Last Updated:	February 15, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Phase I
Volunteer

ClinicalTrials.gov processed this record on May 23, 2013