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

Cognitive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575482
• Other study ID #: CTP140105HT4
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2015
• Last updated: June 3, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

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

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• SUVN-D4010

• Placebo

Locations

Country	Name	City	State
United States	PRA Health Sciences	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG		Range of Day 1-17	Yes
Primary	Physical exams		Range of Day 1-17	Yes
Primary	Vitals signs		Range of Day 1-17	Yes
Primary	CSSRS (suicidality)	Columbia Suicidal Severity Rating Scale	Range of Day 1-17	Yes
Primary	Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects	Incidence of Treatment-Emergent Adverse Events, Laboratory parameters	Range of Day 1-17	Yes
Secondary	Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)		Day 1	No
Secondary	Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)		Day 14	No
Secondary	Maximum observed concentration (Cmax) and time of observation (tmax)		Day 1 and Day 14	No
Secondary	Oral clearance (CL/F)		Day 1 and Day 14	No
Secondary	Accumulation index following multiple dosing of SUVN-D4010 (AI)		Day 14	No
Secondary	Elimination half life (t½)		Day 1 and Day 14	No