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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01007929

Enrollment

Registered

2009-11-05

Start date

2009-10-31

Completion date

2009-11-30

Last updated

2009-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ADME, safety, oral solution

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.

Interventions

DRUG14C-AZD1236

Oral solution 1mg/mL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic profile. Concentration of AZD1236 in plasma	Before and after dosing
Total Radioactivity	Before and after dosing

Secondary

Measure	Time frame
Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination	Before and after dosing

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026