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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-AZD9742

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; [14C]-AZD9742 1000 mg intravenous over 2 hours	Drug: [14C]-AZD9742; 1000 mg intravenous over 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Ralph Schutz, MD, Quintiles, Inc.; Study Director: David Melnick, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 12, 2011

Study Record Updates

• Last Update Posted (Estimate): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Phase 1; radioactivity; metabolism; excretion; AZD9742; healthy male volunteers; amount of radioactive AZD9742 in urine, feces, and vomitus (if appropriate)
• Other Study ID Numbers: D2690C00009