A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects

Study Overview
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Brief Summary
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This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

Detailed Description
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This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions. The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible. The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses 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-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: SUVN-911
* 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 body mass index (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 gastro intestinal (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
Interventional Model Description: subjects randomized to drug or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single ascending dose<br>Single dose of SUVN-911 or placebo in healthy male subjects | Drug: SUVN-911<br>* Oral Tablet<br>Drug: Placebo<br>* Oral Tablet<br>|
| Active Comparator: Multiple ascending dose<br>Multiple doses of SUVN-911 or placebo in healthy male subjects | Drug: SUVN-911<br>* Oral Tablet<br>Drug: Placebo<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG (Electrocardiogram) | electrocardiogram outcomes | Range of Day 1-17 | 
| Vital signs | blood pressure determination | Range of Day 1-17 | 
| C-SSRS (Columbia Suicidal Severity Rating Scale) | Columbia Suicidal Severity Rating in multiple doses | Range of Day 1-17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) | Plasma concentration | Day 1 and Day 14 | 
| Maximum observed concentration (Cmax) | Maximum concentration observed | Day 1 and Day 14 | 
| Time to reach maximum concentration (Tmax) | Determination of maximum time taken to reach the maximum concentration | Day 1 and Day 14 | 
| Terminal half-life (t½) | Elimination rate | 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-911, Depression, single dose, multiple dose, alpha4 beta2 receptor, first in human, safety, pharmacokinetics, tolerability