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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02575482
Study type Interventional
Source Suven Life Sciences Limited
Contact
Status Completed
Phase Phase 1
Start date July 2015
Completion date June 2016

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