Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: AZD5672

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Macclesfield, Cheshire, United Kingdom
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD5672; single dose 200mg aqueous solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Raj Chetty, AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (Estimate): July 8, 2008

Study Record Updates

• Last Update Posted (Estimate): April 9, 2009
• Last Update Submitted That Met QC Criteria: April 8, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: pharmacokinetics; mass balance; AZD5672; radiolabel
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; CCR5 Receptor Antagonists; N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
• Other Study ID Numbers: D1710C00010; 2008-001528-30 (EUdract No)