NCT00940641

Brief Summary

The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

July 15, 2009

Last Update Submit

January 21, 2011

Conditions

AbsorptionDistributionMetabolismExcretion

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration

    Daily

Secondary Outcomes (1)

  • To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325

    Daily

Study Arms (2)

1

EXPERIMENTAL

IV dose of AZD7325

Drug: AZD7325

2

EXPERIMENTAL

14C oral dose of AZD7325

Drug: AZD7325

Interventions

AZD7325DRUG

IV Dose

1

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects Day 1
  • Body Mass Index (BMI) \> 18 and \< 30kg/m2

You may not qualify if:

  • Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
  • Use of prescription medication within 14 days of the first dose of the investigational product
  • Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Alderley Park, United Kingdom

Location

MeSH Terms

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Study Officials

  • Raj Chetty, MBBS, MD, FRCPath.

    AstraZeneca Alderly Park CPU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 16, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

GB(1)