This is a Single Ascending Dose Tolerance Study

Cognition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01133574
• Other study ID #: S354.1.001
• Secondary ID: 2009-017008-10
• Status: Terminated
• Phase: Phase 1
• First received: May 21, 2010
• Last updated: August 25, 2011
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders

Intervention

Drug:
• SLV354 capsules
20 mg
• SLV354 capsules
60 mg
• SLV354 capsules
120 mg
• SLV354 capsules
250 mg
• SLV354 capsules
500 mg
• SLV354 capsules
750 mg
• SLV354 capsules
1000 mg
• SLV354 capsules
1250 mg
• Placebo capsules
placebo
• SLV354 capsules
low dose group 1
• SLV354 capsules
high dose group 1
• SLV354 capsules
low dose group 2
• SLV354 capsules
high dose group 2
• Placebo capsules
placebo

Locations

Country	Name	City	State
United Kingdom	Site Reference ID/Investigator# 62002	London

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)		1 week after each dose level	Yes
Primary	Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)		2 weeks after each dose	Yes
Secondary	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	No
Secondary	Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)		1 week after each dose level	No
Secondary	Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)		2 weeks after each dose	No
Secondary	Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)		2 weeks after each dose	No