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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C] AZD5069

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332903

D3550C00013

Details and patient eligibility

About

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

Enrollment: 6 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Description:

\[14C\] AZD5069

Treatment:

Drug: [14C] AZD5069