This is a Single Ascending Dose Tolerance Study
August 25, 2011 updated by: Abbott
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)
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The Part A of this study is a parallel design followed in a second part by a cross-over design
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SE1 9RT
- Site Reference ID/Investigator# 62002
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: A1
Part A, Parallel design Arm 1
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A2
Part A, Parallel design Arm 2
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A3
Part A, Parallel design Arm 3
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A4
Part A, Parallel design Arm 4
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A5
Part A, Parallel design Arm 5
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A6
Part A, Parallel design Arm 6
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A7
Part A, Parallel design Arm 7
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: A8
Part A, Parallel design Arm 8
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
PLACEBO_COMPARATOR: A9
Part A, Parallel design Arm 9
|
placebo
|
|
EXPERIMENTAL: B1-1
Part B, Cross-over design, Arm 1
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: B1-2
Part B, Cross-over design, Arm 2
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: B2-1
Part B, Cross-over design, Arm 3
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
EXPERIMENTAL: B2-2
Part B, Cross-over design, Arm 4
|
20 mg
60 mg
120 mg
250 mg
500 mg
750 mg
1000 mg
1250 mg
low dose group 1
high dose group 1
low dose group 2
high dose group 2
|
|
PLACEBO_COMPARATOR: B3
Part B, Cross-over design, Arm 5
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)
Time Frame: 1 week after each dose level
|
1 week after each dose level
|
|
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)
Time Frame: 2 weeks after each dose
|
2 weeks after each dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 week after each dose level
|
|
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)
Time Frame: 1 week after each dose level
|
1 week after each dose level
|
|
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
|
2 weeks after each dose
|
|
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)
Time Frame: 2 weeks after each dose
|
2 weeks after each dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
May 21, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (ESTIMATE)
May 31, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 29, 2011
Last Update Submitted That Met QC Criteria
August 25, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S354.1.001
- 2009-017008-10 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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