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

NCT ID: NCT02881294

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Cognitive Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Food Effect

SUVN-G3031 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-G3031

Intervention Type DRUG

Gender Effect

SUVN-G3031 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-G3031

Intervention Type DRUG

Age Effect

SUVN-G3031 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-G3031

Intervention Type DRUG

Interventions

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SUVN-G3031

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suven Life Sciences Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quintiles

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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CTP1S23031H3

Identifier Type: -

Identifier Source: org_study_id