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

This study has been 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.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01007929
First received: October 29, 2009
Last updated: November 19, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Healthy
Drug: 14C-AZD1236
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic profile. Concentration of AZD1236 in plasma [ Time Frame: Before and after dosing ] [ Designated as safety issue: No ]
  • Total Radioactivity [ Time Frame: Before and after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination [ Time Frame: Before and after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: October 2009
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
Experimental: 1
14C-AZD1236
Drug: 14C-AZD1236
Oral solution 1mg/mL

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007929

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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01007929     History of Changes
Other Study ID Numbers: D4260C00010
Study First Received: October 29, 2009
Last Updated: November 19, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
ADME
safety
oral solution

ClinicalTrials.gov processed this record on August 21, 2014