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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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 April 23, 2014