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

June 3, 2016 updated by: Suven Life Sciences Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single and Multiple ascending dose
Single dose of SUVN-D4010 in healthy male subjects
Drug: SUVN-D4010
Placebo Comparator: Placebo
Placebo in healthy male subjects
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suven Life Sciences Limited

Investigators

  • Principal Investigator: Daniel Dickerson, Research Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP140105HT4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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