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

Phase 1

Completed

• Conditions: Cognitive Disorders
• Interventions: Drug: SUVN-G3031; Drug: Placebo

• Registration Number: NCT02342041
• Lead Sponsor: Suven Life Sciences Limited

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-10
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

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 ascending dose	SUVN-G3031	Single dose of SUVN-G3031or placebo in healthy male subjects
Single ascending dose	Placebo	Single dose of SUVN-G3031or placebo in healthy male subjects
Multiple ascending dose	SUVN-G3031	Multiple doses of SUVN-G3031 or placebo in healthy male subjects
Multiple ascending dose	Placebo	Multiple doses of SUVN-G3031 or placebo in healthy male subjects

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects	Range of Day 1-19	Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.

Secondary Outcome Measures

Name	Time	Method
Accumulation index following multiple dosing of SUVN-G3031 (AI)	Day 14
Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)	Day 1
Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)	Day 14
Maximum observed concentration (Cmax) and time of observation (tmax)	Day 1 and Day 14
Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)	Day 1 and Day 14

Trial Locations

Locations (1)

Quintiles; 🇺🇸 Overland Park, Kansas, United States