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First in Man Study With SLV342

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985478
Recruitment Status : Terminated (Terminated on 14 Sep 2010 due to strategic considerations)
First Posted : September 28, 2009
Last Update Posted : August 25, 2011
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Products )

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 28, 2009
Last Update Posted Date August 25, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination. [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2011)
  • Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 28 days ]
  • Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring [ Time Frame: 28 days ]
  • Midazolam PK parameters [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
  • Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR [ Time Frame: 1-28 days ]
  • Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. [ Time Frame: 28 days ]
  • Midazolam PK parameters [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Man Study With SLV342
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
Brief Summary First in man study with single and multiple rising doses with SLV342
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: SLV342
    25 mg once daily - Maximal Tolerated Dose
  • Drug: placebo
    matching placebo
Study Arms  ICMJE
  • Experimental: A
    SLV342 suspension or capsule
    Intervention: Drug: SLV342
  • Placebo Comparator: B
    matching placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 28, 2010)
48
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
119
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Healthy

Exclusion Criteria

  • Not healthy
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985478
Other Study ID Numbers  ICMJE S342.1.001
2009-014245-88 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott ( Abbott Products )
Study Sponsor  ICMJE Abbott Products
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE
Study Director: Ingrid Meuwsen, MS Abbott Healthcare Products B.V
PRS Account Abbott
Verification Date August 2011

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