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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C] AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284595

D0102C00007

Details and patient eligibility

About

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

Enrollment: 6 estimated patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

6 participants in 1 patient group

AZD8931

Experimental group

Description:

\[14C\] AZD8931

Treatment:

Drug: [14C] AZD8931