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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01007929
• Other study ID #: D4260C00010
• Status: Terminated
• Phase: Phase 1
• First received: October 29, 2009
• Last updated: November 19, 2009
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 14C-AZD1236
Oral solution 1mg/mL

Locations

Country	Name	City	State
United Kingdom	Research Site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile. Concentration of AZD1236 in plasma		Before and after dosing	No
Primary	Total Radioactivity		Before and after dosing	No
Secondary	Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination		Before and after dosing	No