Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:May 22, 2018
End Date:July 16, 2018

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A Phase I, Single-Center, Single Dose Study to Evaluate the Effect of Food, Gender, and Age on Safety and Pharmacokinetic Profiles of SUVN-911 Tablets Orally Administered in Healthy Subjects

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

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

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.
We found this trial at
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Kansas City, Kansas 66211
Phone: 913-708-7611
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