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

NCT ID: NCT01275781

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

\[14C\]-AZD9742 1000 mg intravenous over 2 hours

Group Type: EXPERIMENTAL

[14C]-AZD9742

Intervention Type: DRUG

1000 mg intravenous over 2 hours

Interventions

[14C]-AZD9742

1000 mg intravenous over 2 hours

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

David Melnick, MD

Role: STUDY_DIRECTOR

AstraZeneca

Ralph Schutz, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

D2690C00009

Identifier Type: -

Identifier Source: org_study_id