AZD0837 Extended Release (ER) Japan Study

A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00904800

Acronym

ER J ph I

Enrollment

Registered

2009-05-20

Start date

2009-05-31

Completion date

2009-06-30

Last updated

2009-07-13

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

Conditions

Healthy

Keywords

Phase I, Healthy volunteers

Brief summary

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Interventions

DRUGAZD0837

tablet, oral, once daily, 1+5 days

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion criteria

* Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2 * Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2 * Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Design outcomes

Primary

Measure	Time frame
To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.	All assessments are made at each visit, at least daily, during the study.

Secondary

Measure	Time frame
To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.	Blood samples will be taken before and after study drug administration.

Countries

Japan

Outcome results

None listed

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