NCT00711074

Brief Summary

The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1 rheumatoid-arthritis

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

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
Last Updated

April 9, 2009

Status Verified

April 1, 2009

First QC Date

July 3, 2008

Last Update Submit

April 8, 2009

Conditions

Rheumatoid Arthritis

Keywords

pharmacokineticsmass balanceradiolabelAZD5672

Outcome Measures

Primary Outcomes (2)

  • total radioactivity in plasma, whole blood, faeces and urine.

    Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h

  • Additional metabolite identification

    0.5h, 3h, 6h, 12h, 24h

Secondary Outcomes (1)

  • general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs

    Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD5672

Interventions

AZD5672DRUG

single dose 200mg aqueous solution

1

Eligibility Criteria

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

You may qualify if:

  • Body Mass index (BMI) 18-30 kg/m2, inclusive.
  • Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator

You may not qualify if:

  • Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
  • Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
  • Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Macclesfield, Cheshire, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mark Layton

    AstraZeneca

    STUDY DIRECTOR

  • Raj Chetty

    AstraZeneca

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 8, 2008

Study Start

June 1, 2008

Study Completion

July 1, 2008

Last Updated

April 9, 2009

Record last verified: 2009-04

Locations

GB(1)