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

AstraZeneca12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy Volunteers Mass Balance Study

Interventions

AZD3293DRUG

7 subjects will receive AZD3293

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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; \-

Locations (1)

Research Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 25

Secondary Outcomes

Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs).

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.

Time frame: Up to Day 25

The Columbia-Suicide Severity Rating Scale (C-SSRS)

The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess the psychiatric health of subjects.

Time frame: Up to day 25

Time to maximum observed concentration (tmax)

Time to maximum observed concentration (tmax) will be calculated for AZD3293 and its metabolite; and \[14C\]-AZD3293-derived total radioactivity.

Time frame: Up to day 25

Area under the concentration-time curve

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.

Time frame: Up to day 25

Area under the concentration-time curve extrapolated to infinity (AUC0-∞)

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.

Data from ClinicalTrials.gov

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