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

NCT01058447 | Completed Phase 1

• 1 other identifier: D9830C00006
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

ADME; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables and Radioactivity

  Frequent sampling occasions during study days

Secondary Outcomes (1)

• Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

  Frequent sampling occasions during study days

Study Arms (1)

1

EXPERIMENTAL

Drug: AZD1981

Interventions

AZD1981 DRUG

Oral tablet, 250 mg, single dose

1

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

AZD1981

Study Officials

• Eva S Pettersson

  AstraZeneca R&D, Lund, Sweden

  STUDY DIRECTOR

• Tim Mant, Professor

  Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom

  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: January 26, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11