NCT00689247

Brief Summary

The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

1 month

First QC Date

May 30, 2008

Last Update Submit

December 2, 2010

Conditions

Healthy

Keywords

AZD1305ADMEpharmacokineticAbsorptiondistributionmetabolismexcretion

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables

    During all dosing visits

Secondary Outcomes (1)

  • Adverse events, vital signs, ECG, laboratory variables and physical examination

    During the study

Study Arms (2)

A

EXPERIMENTAL

AZD1305 given as oral solution

Drug: AZD1305

B

EXPERIMENTAL

AZD1305 given as iv infusion

Drug: AZD1305

Interventions

AZD1305DRUG

oral solution, single dose

A

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

You may not qualify if:

  • Potassium outside normal reference values
  • ECG findings outside normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Macclesfield, Cheshire, United Kingdom

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

  • Raj Chetty, MBBS, MD

    AstraZeneca CPU Alderley Park, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

GB(1)