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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014