NCT01007929

Brief Summary

The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\] AZD1236 in healthy male subjects.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

First QC Date

October 29, 2009

Last Update Submit

November 19, 2009

Conditions

Healthy

Keywords

ADMEsafetyoral solution

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic profile. Concentration of AZD1236 in plasma

    Before and after dosing

  • Total Radioactivity

    Before and after dosing

Secondary Outcomes (1)

  • Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination

    Before and after dosing

Study Arms (1)

1

EXPERIMENTAL

14C-AZD1236

Drug: 14C-AZD1236

Interventions

14C-AZD1236DRUG

Oral solution 1mg/mL

1

Eligibility Criteria

Age50 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Non-smokers

You may not qualify if:

  • Subjects who are exposed to radiation exposure as part of their occupation
  • Subjects exposed to radiation levels above background of \>5 mSv in last year, \>10 mSv over last 5 years or a cumulative total of \> 1 mSv per year of life
  • A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Macclesfield, CHESHIRE, United Kingdom

Location

Study Officials

  • AstraZeneca CPU Medical Director

    AstraZeneca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2009

First Posted

November 5, 2009

Study Start

October 1, 2009

Study Completion

November 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

GB(1)