Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers (ADME)

An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD1981

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Provision of signed, written and dated informed consent prior to any study specific procedure
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

• Exposed to radiation levels above background 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
• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

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: AZD1981; Oral tablet, 250 mg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables and Radioactivity	Frequent sampling occasions during study days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	Frequent sampling occasions during study days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Eva S Pettersson, AstraZeneca R&D, Lund, Sweden; Principal Investigator: Tim Mant, Professor, Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 28, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2010
• Last Update Submitted That Met QC Criteria: November 17, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteers; ADME
• Other Study ID Numbers: D9830C00006