A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
AZD3293hADME
2 other identifiers
interventional
12
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 16, 2014
June 1, 2014
Same day
April 28, 2014
June 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax) parameters will be calculated, for AZD3293, its metabolite; and \[14C\]-AZD3293-derived total radioactivity.
Up to Day 25
Secondary Outcomes (9)
Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs).
Up to Day 25
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to day 25
Time to maximum observed concentration (tmax)
Up to day 25
Area under the concentration-time curve
Up to day 25
Area under the concentration-time curve extrapolated to infinity (AUC0-∞)
Up to day 25
- +4 more secondary outcomes
Study Arms (1)
AZD3293
EXPERIMENTAL7 subjects will receive AZD3293
Interventions
Eligibility Criteria
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Mirkin, MD
Covance
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
April 30, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 16, 2014
Record last verified: 2014-06