This is a Single Ascending Dose Tolerance Study

Study Overview
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Brief Summary
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This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

Detailed Description
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The Part A of this study is a parallel design followed in a second part by a cross-over design

Official Title
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A Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of SLV354 After Oral Dose Administration in Healthy Adult Male Subjects

Conditions
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Cognition Disorders

Intervention / Treatment
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* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: Placebo capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: SLV354 capsules
* Drug: Placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria BMI 18.0 to 28.0 kg/m2, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg, heart rate 50 100 beats/min (all inclusive), clinically normal safety ECG and laboratory results Exclusion Criteria relevant disease, treated with SLV354 before

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: A1<br>Part A, Parallel design Arm 1 | Drug: SLV354 capsules<br>* 20 mg<br>|
| Experimental: A2<br>Part A, Parallel design Arm 2 | Drug: SLV354 capsules<br>* 60 mg<br>|
| Experimental: A3<br>Part A, Parallel design Arm 3 | Drug: SLV354 capsules<br>* 120 mg<br>|
| Experimental: A4<br>Part A, Parallel design Arm 4 | Drug: SLV354 capsules<br>* 250 mg<br>|
| Experimental: A5<br>Part A, Parallel design Arm 5 | Drug: SLV354 capsules<br>* 500 mg<br>|
| Experimental: A6<br>Part A, Parallel design Arm 6 | Drug: SLV354 capsules<br>* 750 mg<br>|
| Experimental: A7<br>Part A, Parallel design Arm 7 | Drug: SLV354 capsules<br>* 1000 mg<br>|
| Experimental: A8<br>Part A, Parallel design Arm 8 | Drug: SLV354 capsules<br>* 1250 mg<br>|
| Placebo Comparator: A9<br>Part A, Parallel design Arm 9 | Drug: Placebo capsules<br>* placebo<br>|
| Experimental: B1-1<br>Part B, Cross-over design, Arm 1 | Drug: SLV354 capsules<br>* low dose group 1<br>|
| Experimental: B1-2<br>Part B, Cross-over design, Arm 2 | Drug: SLV354 capsules<br>* high dose group 1<br>|
| Experimental: B2-1<br>Part B, Cross-over design, Arm 3 | Drug: SLV354 capsules<br>* low dose group 2<br>|
| Experimental: B2-2<br>Part B, Cross-over design, Arm 4 | Drug: SLV354 capsules<br>* high dose group 2<br>|
| Placebo Comparator: B3<br>Part B, Cross-over design, Arm 5 | Drug: Placebo capsules<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A) |  | 1 week after each dose level | 
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B) |  | 2 weeks after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A) |  | 1 week after each dose level | 
| Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A) |  | 1 week after each dose level | 
| Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B) |  | 2 weeks after each dose | 
| Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B) |  | 2 weeks after each dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, SLV354, Phase I, SRDT