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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cognitive Disorders

Intervention / Treatment
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* Drug: SUVN-D4010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG |  | Range of Day 1-17 | 
| Physical exams |  | Range of Day 1-17 | 
| Vitals signs |  | Range of Day 1-17 | 
| CSSRS (suicidality) | 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 | Incidence of Treatment-Emergent Adverse Events, Laboratory parameters | Range of Day 1-17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUVN-D4010, serotonin 4 (5-HT4) receptor, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose