Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects

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. Identifier: NCT01007929
Recruitment Status : Terminated (Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.)
First Posted : November 5, 2009
Last Update Posted : November 20, 2009
Information provided by:

Brief Summary:
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: 14C-AZD1236 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects
Study Start Date : October 2009
Estimated Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: 1
Drug: 14C-AZD1236
Oral solution 1mg/mL

Primary Outcome Measures :
  1. Pharmacokinetic profile. Concentration of AZD1236 in plasma [ Time Frame: Before and after dosing ]
  2. Total Radioactivity [ Time Frame: Before and after dosing ]

Secondary Outcome Measures :
  1. Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination [ Time Frame: Before and after dosing ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy volunteers
  • Non-smokers

Exclusion Criteria:

  • Subjects who are exposed to radiation exposure as part of their occupation
  • Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
  • A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc

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 identifier (NCT number): NCT01007929

United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
Principal Investigator: AstraZeneca CPU Medical Director AstraZeneca

Responsible Party: MSD, AstraZeneca Identifier: NCT01007929     History of Changes
Other Study ID Numbers: D4260C00010
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by AstraZeneca:
oral solution