This is a Single Ascending Dose Tolerance Study

This study has been terminated.

(Part A completed successfully 22 July 2010, Part B will be separate PET study)

Sponsor:

Collaborator:

Quintiles

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01133574

First received: May 21, 2010

Last updated: August 25, 2011

Last verified: August 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Cognition Disorders	Drug: SLV354 capsules Drug: Placebo capsules	Phase 1

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

Further study details as provided by Abbott:

Primary Outcome Measures:

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A) [ Time Frame: 1 week after each dose level ] [ Designated as safety issue: Yes ]
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B) [ Time Frame: 2 weeks after each dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A) [ Time Frame: 1 week after each dose level ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B) [ Time Frame: 2 weeks after each dose ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	February 2010
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1 Part A, Parallel design Arm 1	Drug: SLV354 capsules 20 mg
Experimental: A2 Part A, Parallel design Arm 2	Drug: SLV354 capsules 60 mg
Experimental: A3 Part A, Parallel design Arm 3	Drug: SLV354 capsules 120 mg
Experimental: A4 Part A, Parallel design Arm 4	Drug: SLV354 capsules 250 mg
Experimental: A5 Part A, Parallel design Arm 5	Drug: SLV354 capsules 500 mg
Experimental: A6 Part A, Parallel design Arm 6	Drug: SLV354 capsules 750 mg
Experimental: A7 Part A, Parallel design Arm 7	Drug: SLV354 capsules 1000 mg
Experimental: A8 Part A, Parallel design Arm 8	Drug: SLV354 capsules 1250 mg
Placebo Comparator: A9 Part A, Parallel design Arm 9	Drug: Placebo capsules placebo
Experimental: B1-1 Part B, Cross-over design, Arm 1	Drug: SLV354 capsules low dose group 1
Experimental: B1-2 Part B, Cross-over design, Arm 2	Drug: SLV354 capsules high dose group 1
Experimental: B2-1 Part B, Cross-over design, Arm 3	Drug: SLV354 capsules low dose group 2
Experimental: B2-2 Part B, Cross-over design, Arm 4	Drug: SLV354 capsules high dose group 2
Placebo Comparator: B3 Part B, Cross-over design, Arm 5	Drug: Placebo capsules placebo

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133574

Locations

United Kingdom
Site Reference ID/Investigator# 62002
London, United Kingdom, SE1 9RT

Sponsors and Collaborators

Abbott

Quintiles

Investigators

Study Director:

Beatrice Rendenbach-Mueller, PhD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01133574 History of Changes
Other Study ID Numbers:	S354.1.001, 2009-017008-10
Study First Received:	May 21, 2010
Last Updated:	August 25, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Abbott:

Healthy volunteers
SLV354
Phase I
SRDT

Additional relevant MeSH terms:

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013

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