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A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293 (AZD3293hADME)

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ClinicalTrials.gov Identifier: NCT02126514
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This study will be an open-label, non-randomized, absorption, metabolism, and excretion study to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing approximately 150 µCi) oral dose (as an oral solution)

Condition or disease Intervention/treatment Phase
Healthy Volunteers Mass Balance Study Drug: AZD3293 Phase 1

Detailed Description:
This study will be an open-label, non-randomized,absorption, metabolism, and excretion study to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing approximately 150 µCi) oral dose (as an oral solution) following at least an 8-hour fast from food (not including water). Seven healthy male subjects will be enrolled in the study at a single study site to complete a minimum of 6 subjects. The study will consist of 2 visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion After Oral Administration of [14C]-AZD3293 to Healthy Male Subjects
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arm Intervention/treatment
Experimental: AZD3293
7 subjects will receive AZD3293
Drug: AZD3293
7 subjects will receive AZD3293




Primary Outcome Measures :
  1. PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax) [ Time Frame: Up to Day 25 ]
    Maximum observed concentration (Cmax) parameters will be calculated, for AZD3293, its metabolite; and [14C]-AZD3293-derived total radioactivity.


Secondary Outcome Measures :
  1. Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs). [ Time Frame: Up to Day 25 ]
    Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs), will be performed before and following investigational product administration.

  2. The Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to day 25 ]
    The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess the psychiatric health of subjects.

  3. Time to maximum observed concentration (tmax) [ Time Frame: Up to day 25 ]
    Time to maximum observed concentration (tmax) will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.

  4. Area under the concentration-time curve [ Time Frame: Up to day 25 ]
    Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity concentrations.

  5. Area under the concentration-time curve extrapolated to infinity (AUC0-∞) [ Time Frame: Up to day 25 ]
    Area under the concentration-time curve extrapolated to infinity (AUC0-∞), apparent terminal elimination rate constant (λZ), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity.

  6. Apparent terminal elimination half-life (t1/2) [ Time Frame: Up to day 25 ]
    Apparent terminal elimination half-life (t1/2), will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.

  7. Apparent oral clearance (CL/F) [ Time Frame: Up to day 25 ]
    Apparent oral clearance (CL/F) (AZD3293 only), will be calculated for AZD3293 concentrations.

  8. Apparent volume of distribution (Vz/F) [ Time Frame: Up to day 25 ]
    Apparent volume of distribution (Vz/F) (AZD3293 only) will be calculated for AZD3293 concentrations.

  9. Ratios for AUC0- [ Time Frame: Up to day 25 ]
    Ratios for AUC0- including the ratio of total radioactivity in whole blood/plasma; and the ratio of AZD3293 in plasma and total radioactivity in plasma, will be calculated.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture; 2) Body weight between 50 to 100 kg, inclusive; 3) Within BMI range 19 to 30 kg/m2, inclusive; 4) In good health, as determined by no clinically significant findings from medical history, physical examination with neurological examination, 12-lead ECG, and vital signs as judged by the Investigator;

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Exclusion Criteria:

Participation in any prior study of AZD3293 or previous enrollment in the present study; 2) Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study; 3) History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126514


Locations
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United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Irene Mirkin, MD Covance

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02126514     History of Changes
Other Study ID Numbers: D5010C00007
AZD3293 hADME ( Other Identifier: AstraZeneca )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by AstraZeneca:
Beta secretase inhibitor
Alzheimer disease