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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax)
Study Overview
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)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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;
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;
Arms & Interventions
AZD3293
7 subjects will receive AZD3293
Intervention: AZD3293 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Time to maximum observed concentration (tmax)(Up to day 25)
- 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)
- Area under the concentration-time curve(Up to day 25)
- Area under the concentration-time curve extrapolated to infinity (AUC0-∞)(Up to day 25)
- Apparent terminal elimination half-life (t1/2)(Up to day 25)
- Apparent oral clearance (CL/F)(Up to day 25)
- Apparent volume of distribution (Vz/F)(Up to day 25)
- Ratios for AUC0-(Up to day 25)