This is a Single Ascending Dose Tolerance Study

Phase 1

Terminated

• Conditions: Cognition Disorders
• Interventions: Drug: SLV354 capsules; Drug: Placebo capsules

• Registration Number: NCT01133574
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-31
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	SLV354 capsules	Part A, Parallel design Arm 1
A2	SLV354 capsules	Part A, Parallel design Arm 2
A3	SLV354 capsules	Part A, Parallel design Arm 3
A4	SLV354 capsules	Part A, Parallel design Arm 4
A5	SLV354 capsules	Part A, Parallel design Arm 5
A6	SLV354 capsules	Part A, Parallel design Arm 6
A7	SLV354 capsules	Part A, Parallel design Arm 7
A8	SLV354 capsules	Part A, Parallel design Arm 8
A9	Placebo capsules	Part A, Parallel design Arm 9
B1-1	SLV354 capsules	Part B, Cross-over design, Arm 1
B1-2	SLV354 capsules	Part B, Cross-over design, Arm 2
B2-1	SLV354 capsules	Part B, Cross-over design, Arm 3
B2-2	SLV354 capsules	Part B, Cross-over design, Arm 4
B3	Placebo capsules	Part B, Cross-over design, Arm 5

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 62002; 🇬🇧 London, United Kingdom