NCT00738322

Brief Summary

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

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 Jul 2008

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

July 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

July 11, 2008

Last Update Submit

June 29, 2009

Conditions

Healthy

Keywords

AZD1305safetypharmacokineticssingle ascending dosesJapanesemale

Outcome Measures

Primary Outcomes (1)

  • Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight

    During the study

Secondary Outcomes (1)

  • Pharmacokinetic variables

    During the dosing visits

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD1305

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1305DRUG

Solution for iv infusion, single dose

1
PlaceboDRUG

NaCl solution for iv infusion, single dose

2

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
  • Japanese males

You may not qualify if:

  • ECG findings outside normal reference ranges.
  • Potassium outside normal reference ranges.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Study Officials

  • Helen Lunde, MD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Kyoko Matsuguma, MD

    Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Study Completion

October 1, 2008

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

JP(1)