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

Tracking Information

First Received Date ^ICMJE

May 21, 2010

Last Updated Date

August 25, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A) [ Time Frame: 1 weeks 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 ]

Change History

Complete list of historical versions of study NCT01133574 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 weeks 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 weeks 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

This is a Single Ascending Dose Tolerance Study

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Cognition Disorders

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A1
Part A, Parallel design Arm 1

Intervention: Drug: SLV354 capsules
Experimental: A2
Part A, Parallel design Arm 2

Intervention: Drug: SLV354 capsules
Experimental: A3
Part A, Parallel design Arm 3

Intervention: Drug: SLV354 capsules
Experimental: A4
Part A, Parallel design Arm 4

Intervention: Drug: SLV354 capsules
Experimental: A5
Part A, Parallel design Arm 5

Intervention: Drug: SLV354 capsules
Experimental: A6
Part A, Parallel design Arm 6

Intervention: Drug: SLV354 capsules
Experimental: A7
Part A, Parallel design Arm 7

Intervention: Drug: SLV354 capsules
Experimental: A8
Part A, Parallel design Arm 8

Intervention: Drug: SLV354 capsules
Placebo Comparator: A9
Part A, Parallel design Arm 9

Intervention: Drug: Placebo capsules
Experimental: B1-1
Part B, Cross-over design, Arm 1

Intervention: Drug: SLV354 capsules
Experimental: B1-2
Part B, Cross-over design, Arm 2

Intervention: Drug: SLV354 capsules
Experimental: B2-1
Part B, Cross-over design, Arm 3

Intervention: Drug: SLV354 capsules
Experimental: B2-2
Part B, Cross-over design, Arm 4

Intervention: Drug: SLV354 capsules
Placebo Comparator: B3
Part B, Cross-over design, Arm 5

Intervention: Drug: Placebo capsules

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01133574

Other Study ID Numbers ^ICMJE

S354.1.001, 2009-017008-10

Has Data Monitoring Committee

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Quintiles

Investigators ^ICMJE

Study Director:

Beatrice Rendenbach-Mueller, PhD

Abbott

Information Provided By

Abbott

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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