- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985478
First in Man Study With SLV342
August 24, 2011 updated by: Abbott Products
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
First in man study with single and multiple rising doses with SLV342
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
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 1YR
- Site Reference ID/Investigator# 61142
-
-
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
- Healthy
Exclusion Criteria
- Not healthy
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
SLV342 suspension or capsule
|
25 mg once daily - Maximal Tolerated Dose
|
Placebo Comparator: B
matching placebo
|
matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination
Time Frame: 28 Days
|
28 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR
Time Frame: 28 days
|
28 days
|
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring
Time Frame: 28 days
|
28 days
|
Midazolam PK parameters
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ingrid Meuwsen, MS, Abbott Healthcare Products B.V
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
January 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Estimate)
August 25, 2011
Last Update Submitted That Met QC Criteria
August 24, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S342.1.001
- 2009-014245-88 (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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