Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects (SUVN-911)
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring SUVN-911, Depression, alpha4 beta2 receptor
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects, 18 to 45 years of age (inclusive) for Cohort 1, healthy female subjects, 18 to 45 years of age (inclusive) for Cohort 2, and healthy male subjects ≥ 65 years of age (inclusive) for Cohort 3, at the time of signing the informed consent.
Subjects in Cohorts 1 and 2 must have a body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive). Elderly subjects in Cohort 3 must have a body weight of at least 50 kg and BMI within the range of 18 to 32 kg/m2 (inclusive)
Exclusion Criteria:
History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 28 days of the first administration of the study treatment (Day 1).
Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
Any positive result at Screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
Sites / Locations
- IQVIA Phase One Services, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Food Effect Cohort
Gender Effect Cohort
Age Effect Cohort
Twelve healthy male subjects 18 to 45 years of age, inclusive, will be administered a single oral dose of SUVN-911 on Day 1 (Period 1) and Day 8 (Period 2) with and without food in a crossover manner.
Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911.
Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911.