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

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, Non-randomized, Single-Center Study to Assess Distribution, Metabolism and Excretion After [14C]-Labelled Intravenous Administration of AZD9742 as a 2-hour Infusion to Healthy Male Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01275781
• Other study ID #: D2690C00009
• Status: Withdrawn
• Phase: Phase 1
• First received: January 11, 2011
• Last updated: January 28, 2013
• Start date: January 2011
• Est. completion date: February 2011

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-AZD9742
1000 mg intravenous over 2 hours

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.	12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.	Range of 12 hours pre dose to 168 hours post dose	No
Primary	To evaluate the excretion of 14C (mass balance) in urine and feces after a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.	12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.	Range of 12 hours pre dose to 168 hours post dose	No
Secondary	Safety of AZD9742 after a single intravenous 14C administration of AZD9742, by assessing a panel of measures: Adverse Events, vital sign evaluations, physical examination, electrocardiograms (ECG) and clinical laboratory parameters.			Yes
Secondary	To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined.		Immediately prior to the end of the infusion, 4 hours after the end of the infusion and 24 hours after the start of the infusion.	No