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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

May 21, 2010
August 25, 2011
February 2010
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01133574 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
This is a Single Ascending Dose Tolerance Study
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

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

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cognition Disorders
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01133574
S354.1.001, 2009-017008-10
No
Abbott
Abbott
Quintiles
Study Director: Beatrice Rendenbach-Mueller, PhD Abbott
Abbott
August 2011

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