A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.

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Detailed Description

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This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-G3031 in healthy male subjects.

Conditions

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Cognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single ascending dose

Single dose of SUVN-G3031or placebo in healthy male subjects

Group Type PLACEBO_COMPARATOR

SUVN-G3031

Intervention Type DRUG

Placebo

Intervention Type DRUG

Multiple ascending dose

Multiple doses of SUVN-G3031 or placebo in healthy male subjects

Group Type PLACEBO_COMPARATOR

SUVN-G3031

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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SUVN-G3031

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).

Exclusion Criteria

* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes