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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: 14C-AZD1236

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007929

D4260C00010

Details and patient eligibility

About

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.

Enrollment: 4 estimated patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

1

Experimental group

Description:

14C-AZD1236

Treatment:

Drug: 14C-AZD1236