Back to resultsA Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Primary Purpose
Cognitive Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SUVN-G3031
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Disorders
Eligibility Criteria
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.
Sites / Locations
- Quintiles
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Food Effect
Gender Effect
Age Effect
Arm Description
SUVN-G3031 tablets single dose
SUVN-G3031 tablets single dose
SUVN-G3031 tablets single dose
Outcomes
Primary Outcome Measures
Area under concentration (AUC)
Maximum observed concentration (Cmax)
Secondary Outcome Measures
Full Information
NCT ID
NCT02881294
First Posted
August 18, 2016
Last Updated
September 21, 2017
Sponsor
Suven Life Sciences Limited
1. Study Identification
Unique Protocol Identification Number
NCT02881294
Brief Title
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suven Life Sciences Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food Effect
Arm Type
Active Comparator
Arm Description
SUVN-G3031 tablets single dose
Arm Title
Gender Effect
Arm Type
Active Comparator
Arm Description
SUVN-G3031 tablets single dose
Arm Title
Age Effect
Arm Type
Active Comparator
Arm Description
SUVN-G3031 tablets single dose
Intervention Type
Drug
Intervention Name(s)
SUVN-G3031
Primary Outcome Measure Information:
Title
Area under concentration (AUC)
Time Frame
96 hours
Title
Maximum observed concentration (Cmax)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Quintiles
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
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