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

Phase 1CompletedNCT01332903

AstraZeneca6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C] AZD5069DRUG

Single 120 mg oral dose administered on Day 1

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

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

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)).

Time frame: From pre-dose until 168 hours post last dose

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).

Time frame: 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.

Time frame: From pre-dose until 168hours post last dose

Secondary Outcomes

To investigate the safety and tolerability of AZD5069 given orally

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.

Time frame: From screening visit, Day 12, up to follow up visit

Data from ClinicalTrials.gov

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