Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Radiation: 150 mg [14C] AZD6765

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217645

D6702C00030

Details and patient eligibility

About

This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must have a normal creatinine clearance of ≥60 mL/min
• Subjects who self-identify their race as Asian

Exclusion criteria

• History of any clinically significant medical, neurologic or psychiatric disease as judged by the investigator
• History of symptomatic orthostatic hypotension (ie, postural syncope)
• Subjects who have received any radiolabelled study drug within 12 months of the Screening Visit.
• Subjects who are monitored for radioactivity as part of their occupation
• Subjects who have been exposed to radiation levels above background, (eg, throughX-Ray examinations) of >5mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1mSv per year of life.

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

150 mg [14C] AZD6765

Experimental group

Treatment:

Radiation: 150 mg [14C] AZD6765