Clinical trial NCT02126514: A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Mass Balance Study
Keywords: Beta secretase inhibitor
Alzheimer disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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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Primary outcomes:
measure: PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax)
timeFrame: Up to Day 25
Secondary outcomes:
measure: Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs).
timeFrame: Up to Day 25
measure: The Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to day 25
measure: Time to maximum observed concentration (tmax)
timeFrame: Up to day 25
measure: Area under the concentration-time curve
timeFrame: Up to day 25
measure: Area under the concentration-time curve extrapolated to infinity (AUC0-∞)
timeFrame: Up to day 25
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: Up to day 25
measure: Apparent oral clearance (CL/F)
timeFrame: Up to day 25
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to day 25
measure: Ratios for AUC0-
timeFrame: Up to day 25
Other outcomes:
Locations:
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Covance
name: Irene Mirkin, MD
role: PRINCIPAL_INVESTIGATOR
References: