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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058447
First Posted: January 28, 2010
Last Update Posted: November 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981

Condition Intervention Phase
Healthy Drug: AZD1981 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic variables and Radioactivity [ Time Frame: Frequent sampling occasions during study days ]

Secondary Outcome Measures:
  • Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ]

Enrollment: 4
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1981
Oral tablet, 250 mg, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058447


Sponsors and Collaborators
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
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01058447     History of Changes
Other Study ID Numbers: D9830C00006
First Submitted: January 26, 2010
First Posted: January 28, 2010
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
ADME
Healthy volunteers