A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
- Registration Number
- NCT02881294
- Lead Sponsor
- Suven Life Sciences Limited
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Food Effect SUVN-G3031 SUVN-G3031 tablets single dose Age Effect SUVN-G3031 SUVN-G3031 tablets single dose Gender Effect SUVN-G3031 SUVN-G3031 tablets single dose
- Primary Outcome Measures
Name Time Method Area under concentration (AUC) 96 hours Maximum observed concentration (Cmax) Day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quintiles
🇺🇸Overland Park, Kansas, United States