Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01332903

Enrollment

Registered

2011-04-11

Start date

2011-05-31

Completion date

2011-07-31

Last updated

2015-06-25

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

Conditions

Healthy

Brief summary

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.

Interventions

DRUG[14C] AZD5069

Single 120 mg oral dose administered on Day 1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Have a body mass index (BMI) of ≥18 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-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1 * Healthy Male volunteers aged 50 and over

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 last 5 years * History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Design outcomes

Primary

Measure	Time frame	Description
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood	From pre-dose until 168 hours post last dose	To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \[14C\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax).	From pre-dose until 168hours post last dose	—
To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance.	From pre-dose until 168hours post last dose	—

Secondary

Measure	Time frame	Description
To investigate the safety and tolerability of AZD5069 given orally	From screening visit, Day 12, up to follow up visit	Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026