A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Suven Life Sciences Limited1 site in 1 country64 target enrollmentMay 22, 2017

ConditionsDepressive Disorder, Major

InterventionsPlacebo SUVN-911

DrugsSUVN-911 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Depressive Disorder, Major
Sponsor: Suven Life Sciences Limited
Enrollment: 64
Locations: 1
Primary Endpoint: C-SSRS (Columbia Suicidal Severity Rating Scale)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

Detailed Description

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions. The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible. The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.

Registry

clinicaltrials.gov

Start Date

May 22, 2017

End Date

March 14, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Suven Life Sciences Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male aged 18 to 45 years with a body mass index (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 gastro intestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.