Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers (ADME)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [C14]AZD9668

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147549

D0520C00016

Details and patient eligibility

About

The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD9668.

Enrollment: 4 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedure
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion criteria

• Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

1

Experimental group

Description:

\[C14\]AZD9668

Treatment:

Drug: [C14]AZD9668