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

Suven Life Sciences Limited1 site in 1 country24 target enrollmentAugust 2016

InterventionsSUVN-G3031

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.