AZD7325 Japan Multiple Ascending Dose (MAD) Study

NCT00945425 | Terminated Phase 1

• 1 other identifier: D1140C00015
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Phase I; Volunteer

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• 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).

• To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).

  Observations/Assessments are made during the treatment visit.

Study Arms (4)

1

EXPERIMENTAL

Low dose or placebo, twice daily

Drug: AZD7325; Drug: Placebo

2

EXPERIMENTAL

Low dose or placebo, once daily

Drug: AZD7325; Drug: Placebo

3

EXPERIMENTAL

Middle dose or placebo, twice daily

Drug: AZD7325; Drug: Placebo

4

EXPERIMENTAL

High dose or placebo, once daily

Drug: AZD7325; Drug: Placebo

Interventions

AZD7325 DRUG

oral capsule, once or twice daily, 7 days

1; 2; 3; 4

Placebo DRUG

oral capsule, once or twice daily, 7 days

1; 2; 3; 4

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Study Officials

• Yuji Kumagai, MD, PhD

  Kitasato University East Hospital, Kanagawa, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 16, 2011

Record last verified: 2011-02