This is a Single Ascending Dose Tolerance Study

Phase 1TerminatedNCT01133574

Abbott47 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cognition Disorders

Interventions

SLV354 capsulesDRUG

20 mg

SLV354 capsulesDRUG

60 mg

SLV354 capsulesDRUG

120 mg

SLV354 capsules

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site Reference ID/Investigator# 62002

London, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

Time frame: 1 week after each dose level

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)

Time frame: 2 weeks after each dose

Secondary Outcomes

Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A)

Time frame: 1 week after each dose level

Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)

Time frame: 1 week after each dose level

Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)

Time frame: 2 weeks after each dose

Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)

Time frame: 2 weeks after each dose

Data from ClinicalTrials.gov

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