NCT02575482

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.

Detailed description

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 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-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,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-D4010 in healthy male subjects.

Conditions

• Cognitive Disorders

Interventions

Type	Name	Description
DRUG	SUVN-D4010
DRUG	Placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2015-10-14
• Last updated: 2016-06-06

Locations

1 site across 1 country: United States