A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Cognitive Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881294
• Other study ID #: CTP1S23031H3
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2016
• Last updated: September 21, 2017
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• SUVN-G3031

Locations

Country	Name	City	State
United States	Quintiles	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under concentration (AUC)		96 hours
Primary	Maximum observed concentration (Cmax)		Day 1