NCT00904800

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

First QC Date

May 13, 2009

Last Update Submit

July 10, 2009

Conditions

Healthy

Keywords

Phase IHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (4)

1

EXPERIMENTAL

Low dose

Drug: AZD0837

2

EXPERIMENTAL

Middle dose

Drug: AZD0837

3

EXPERIMENTAL

High dose

Drug: AZD0837

4

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

AZD0837DRUG

tablet, oral, once daily, 1+5 days

123
PlaceboDRUG

Placebo

4

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Kagoshima, Japan

Location

MeSH Terms

Interventions

AZD 0837

Study Officials

  • Hiroyuki Fukase, MD, PhD

    CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 20, 2009

Study Start

May 1, 2009

Study Completion

June 1, 2009

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

JP(1)