A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Status: | Recruiting |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 5/4/2017 |
Start Date: | August 2016 |
End Date: | July 2017 |
Contact: | Barbara Lomeli, MD |
Email: | Barbara.Lomeli@quintiles.com |
Phone: | 913 777-1128 |
A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy Subjects
The purpose of the study is to investigate the effect of Food, Gender, and Age on the
Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Inclusion Criteria:
- Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2,
(inclusive) for food and gender effect
- Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for
age effect
Exclusion Criteria:
- History or presence of GI, hepatic, or renal disease or any other condition known to
interfere with absorption, distribution, metabolism, or excretion of drugs as judged
by Investigator.
- Any clinically important illness, medical/surgical procedure, or trauma within 4
weeks of the first administration of the study drug.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg),
hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
- 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.
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