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

Suven Life Sciences

Status and phase: Completed; Phase 1

Conditions: Cognitive Disorders

Treatments: Drug: SUVN-G3031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02342041

CTP13031H3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Single ascending dose

Placebo Comparator group

Description:

Single dose of SUVN-G3031or placebo in healthy male subjects

Treatment:

Drug: SUVN-G3031

Drug: Placebo

Multiple ascending dose

Placebo Comparator group

Description:

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

Treatment:

Drug: SUVN-G3031

Drug: Placebo