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

This study has been withdrawn prior to enrollment.
(Withdrawn due to the local Radiation Safety Committee refusing to approve it.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01275781
First received: January 11, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: [14C]-AZD9742
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: Range of 12 hours pre dose to 168 hours post dose ] [ Designated as safety issue: No ]
    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.

  • 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. [ Time Frame: Range of 12 hours pre dose to 168 hours post dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]
  • To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
[14C]-AZD9742 1000 mg intravenous over 2 hours
 Drug: [14C]-AZD9742
1000 mg intravenous over 2 hours

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275781

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: David Melnick, MD AstraZeneca
Principal Investigator: Ralph Schutz, MD Quintiles
  More Information

No publications provided

Responsible Party: Medical Science Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01275781     History of Changes
Other Study ID Numbers: D2690C00009
Study First Received: January 11, 2011
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
healthy male volunteers
radioactivity
excretion
 metabolism
AZD9742
amount of radioactive AZD9742 in urine, feces, and vomitus (if appropriate)

ClinicalTrials.gov processed this record on May 16, 2013