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

Phase 1

Completed

• Conditions: Cognitive Disorders
• Interventions: Drug: SUVN-D4010; Drug: Placebo

• Registration Number: NCT02575482
• Lead Sponsor: Suven Life Sciences Limited

Brief 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Primary Completion: 2016-02
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single and Multiple ascending dose	SUVN-D4010	Single dose of SUVN-D4010 in healthy male subjects
Placebo	Placebo	Placebo in healthy male subjects

Primary Outcome Measures

Name	Time	Method
ECG	Range of Day 1-17
Physical exams	Range of Day 1-17
Vitals signs	Range of Day 1-17
CSSRS (suicidality)	Range of Day 1-17	Columbia Suicidal Severity Rating Scale
Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects	Range of Day 1-17	Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

Secondary Outcome Measures

Name	Time	Method
Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)	Day 1
Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)	Day 14
Maximum observed concentration (Cmax) and time of observation (tmax)	Day 1 and Day 14
Oral clearance (CL/F)	Day 1 and Day 14
Accumulation index following multiple dosing of SUVN-D4010 (AI)	Day 14
Elimination half life (t½)	Day 1 and Day 14

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Lenexa, Kansas, United States