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Single and Multiple Ascending Doses of AZD1981 in Japan

A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00698282
Acronym
JSAD/JMAD
Enrollment
47
Registered
2008-06-17
Start date
2008-08-31
Completion date
2008-10-31
Last updated
2010-12-01

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

Conditions

Healthy

Brief summary

The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Interventions

Oral tablet, 250 mg single dose

DRUGPlacebo

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy Japanese and Caucasian males

Exclusion criteria

* Other clinically relevant disease or disorders

Design outcomes

Primary

MeasureTime frame
Adverse eventsAll the time
Plasma drug concentrationEvery hour

Secondary

MeasureTime frame
Clinical chemistryday 1 and 9

Countries

United Kingdom

Outcome results

None listed

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