Study in Healthy Males to Assess Distribution, Metabolism, and Excretion of Radio-labelled AZD9742 Administered as a 2-hour Infusion

AstraZeneca

Status and phase

Withdrawn

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-AZD9742

Study type

Interventional

Funder types

Industry

Identifiers

NCT01275781

D2690C00009

Details and patient eligibility

About

The purpose of this study is to assess distribution, metabolism, and excretion of radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.

Sex

Male

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers age 55 years or older on Day 1, body weight >50 kg, body mass index (BMI) between 18 kg/m2 and 30 kg/m2
Regular bowel movements, at least once per day (self reported)
Volunteers must be willing to have intravenous (IV) and blood sampling from either arm.
Volunteers should ensure that their partners of child-bearing potential use a reliable method of contraception, as well as using a barrier method themselves.

Exclusion criteria

History of any clinically significant disease or abnormalities, including history or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Current smokers or those who have smoked or used nicotine products within the previous 30 days
History of alcohol abuse or excessive intake of alcohol
Participation in more than 1 other radiolabeled investigational study drug trial within 1 year prior to check-in. The previous radiolabeled study drug had to be received more than 6 months prior to check-in and the total exposure from this study and the previous study must be within the CFR recommended levels considered safe (per 21 CRF 362.1, less than 5,000 mrem whole body annual exposure).