Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931

[14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284595

Enrollment

Registered

2011-01-27

Start date

2011-03-31

Completion date

2011-05-31

Last updated

2014-08-13

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

Conditions

Healthy

Keywords

Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers

Brief summary

Study to Assess the Absorption, Metabolism and Excretion of \[14C\]AZD8931 after a Single-Dose Oral Administration

Interventions

DRUG[14C] AZD8931

Single 160 mg oral dose administered on Day 1

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg. * Regular daily bowel movements (ie, production of at least 1 stool per day). * Non-smokers or ex-smokers who have stopped smoking for \>3 months before Visit 1 and have not used nicotine products for \>3 months * Healthy Male volunteers aged 50 to 65 years, inclusive

Exclusion criteria

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life * Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1). * History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)

Design outcomes

Primary

Measure	Time frame
To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects	Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose
To investigate the pharmacokinetic variable of AZD8931 in plasma	Multiple PK blood samples from pre-dose until 240 hours post last dose

Secondary

Measure	Time frame
To investigate the safety and tolerability of AZD8931 given orally	Frequent safety measurements during the study from screening period to follow-up
To investigate the AZD8931 metabolites variables in plasma	Multiple PK blood samples from pre-dose until 240 hours post last dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026