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

Suven Life Sciences Limited64 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cognitive Disorders

Interventions

SUVN-D4010DRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PRA Health Sciences

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

ECG

Time frame: Range of Day 1-17

Physical exams

Time frame: Range of Day 1-17

Vitals signs

Time frame: Range of Day 1-17

CSSRS (suicidality)

Columbia Suicidal Severity Rating Scale

Time frame: Range of Day 1-17

Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects

Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

Time frame: Range of Day 1-17

Secondary Outcomes

Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)

Time frame: Day 1

Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)

Time frame: Day 14

Maximum observed concentration (Cmax) and time of observation (tmax)

Time frame: Day 1 and Day 14

Oral clearance (CL/F)

Time frame: Day 1 and Day 14

Accumulation index following multiple dosing of SUVN-D4010 (AI)

Time frame: Day 14

Elimination half life (t½)

Time frame: Day 1 and Day 14

Data from ClinicalTrials.gov

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