AZD7325 Japan Multiple Ascending Dose (MAD) Study

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945425

Acronym

JMAD

Enrollment

Registered

2009-07-24

Start date

2009-07-31

Completion date

2009-11-30

Last updated

2011-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, Volunteer

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.

Interventions

DRUGAZD7325

oral capsule, once or twice daily, 7 days

DRUGPlacebo

oral capsule, once or twice daily, 7 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026