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

NCT01275781 | Withdrawn Phase 1

• 1 other identifier: D2690C00009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Phase 1; healthy male volunteers; radioactivity; excretion; metabolism; AZD9742; amount of radioactive AZD9742 in urine, feces, and vomitus (if appropriate)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Study Arms (1)

A

EXPERIMENTAL

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

Drug: [14C]-AZD9742

Interventions

[14C]-AZD9742 DRUG

1000 mg intravenous over 2 hours

A

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Melnick, MD

  AstraZeneca

  STUDY DIRECTOR

• Ralph Schutz, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)