Major Depressive Disorder
Conditions
Keywords
SUVN-911, Depression, alpha4 beta2 receptor
Brief summary
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
Detailed description
This is a Phase I, single-center, open-label, single dose study to evaluate the effect of food, gender, and age on the safety and Pharmacokinetic profiles of single doses of SUVN-911, administered orally in healthy subjects. The primary objective is to evaluate the effect of food, gender, and age on the pharmacokinetics of a single dose of SUVN-911 administered orally to healthy subjects. The secondary objective is to evaluate the safety and tolerability of a single dose of SUVN-911 administered orally to healthy adult male, female, and elderly subjects
Interventions
DRUGSUVN-911
Tablet
Sponsors
Suven Life Sciences Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be enrolled in 1 of 3 cohorts; Cohort 1 (Food Effect Cohort), Cohort 2 (Gender Effect Cohort), and Cohort 3 (Age Effect Cohort). Subjects in Cohort 1 will receive a single oral dose of SUVN-911 on Day 1 under fasted or fed conditions and again on Day 8 under fasted or fed conditions (crossover design). Subjects in Cohort 2 and Cohort 3 will receive a single oral dose of SUVN-911 on Day 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration (AUC) | 24 hours | Plasma concentration versus time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | 24 hours | blood pressure determination |
Countries
United States
Outcome results
None listed