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This is a Single Ascending Dose Tolerance Study

Primary Purpose

Cognition Disorders

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

SLV354 capsules

Placebo capsules

SLV354 capsules

Placebo capsules

About this trial

This is an interventional treatment trial for Cognition Disorders focused on measuring Healthy volunteers, SLV354, Phase I, SRDT

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Site Reference ID/Investigator# 62002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

B1-1

B1-2

B2-1

B2-2

Arm Description

Part A, Parallel design Arm 1

Part A, Parallel design Arm 2

Part A, Parallel design Arm 3

Part A, Parallel design Arm 4

Part A, Parallel design Arm 5

Part A, Parallel design Arm 6

Part A, Parallel design Arm 7

Part A, Parallel design Arm 8

Part A, Parallel design Arm 9

Part B, Cross-over design, Arm 1

Part B, Cross-over design, Arm 2

Part B, Cross-over design, Arm 3

Part B, Cross-over design, Arm 4

Part B, Cross-over design, Arm 5

Outcomes

Primary Outcome Measures

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)

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)

Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)

Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)

Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)

Full Information

NCT ID

NCT01133574

First Posted

May 21, 2010

Last Updated

August 25, 2011

Sponsor

Abbott

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01133574

Brief Title

This is a Single Ascending Dose Tolerance Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

February 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

Collaborators

Quintiles, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognition Disorders

Keywords

Healthy volunteers, SLV354, Phase I, SRDT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 1

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 2

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 3

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 4

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 5

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 6

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 7

Arm Title

Arm Type

Experimental

Arm Description

Part A, Parallel design Arm 8

Arm Title

Arm Type

Placebo Comparator

Arm Description

Part A, Parallel design Arm 9

Arm Title

B1-1

Arm Type

Experimental

Arm Description

Part B, Cross-over design, Arm 1

Arm Title

B1-2

Arm Type

Experimental

Arm Description

Part B, Cross-over design, Arm 2

Arm Title

B2-1

Arm Type

Experimental

Arm Description

Part B, Cross-over design, Arm 3

Arm Title

B2-2

Arm Type

Experimental

Arm Description

Part B, Cross-over design, Arm 4

Arm Title

Arm Type

Placebo Comparator

Arm Description

Part B, Cross-over design, Arm 5

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

20 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

60 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

120 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

250 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

500 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

750 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

1000 mg

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

1250 mg

Intervention Type

Drug

Intervention Name(s)

Placebo capsules

Intervention Description

placebo

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

low dose group 1

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

high dose group 1

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

low dose group 2

Intervention Type

Drug

Intervention Name(s)

SLV354 capsules

Intervention Description

high dose group 2

Intervention Type

Drug

Intervention Name(s)

Placebo capsules

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

Time Frame

1 week after each dose level

Title

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)

Time Frame

2 weeks after each dose

Secondary Outcome Measure Information:

Title

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

Title

Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)

Time Frame

1 week after each dose level

Title

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

Title

Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)

Time Frame

2 weeks after each dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatrice Rendenbach-Mueller, PhD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 62002

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

This is a Single Ascending Dose Tolerance Study

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