Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058447

Acronym

ADME

Enrollment

Registered

2010-01-28

Start date

2010-02-28

Completion date

2010-03-31

Last updated

2010-11-18

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

Conditions

Healthy

Keywords

ADME, Healthy volunteers

Brief summary

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\]AZD1981

Interventions

DRUGAZD1981

Oral tablet, 250 mg, single dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed, written and dated informed consent prior to any study specific procedure * Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion criteria

* Exposed to radiation levels above background of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life * History or presence of any clinically significant disease or disorder in the opinion of the investigator * Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables and Radioactivity	Frequent sampling occasions during study days

Secondary

Measure	Time frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	Frequent sampling occasions during study days

Outcome results

None listed

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