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Safety Study of SPC3649 in Healthy Men

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: NCT00688012
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Santaris Pharma A/S

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE June 2, 2008
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of SPC3649 in Healthy Men
Official Title  ICMJE A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Brief Summary A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: SPC3649
Study Arms  ICMJE Not Provided
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 Completed
Enrollment  ICMJE
 (submitted: January 9, 2009)
64
Original Enrollment  ICMJE
 (submitted: May 30, 2008)
48
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Volunteers
  • BMI: 19-28 kg/m2
  • No clinically significant disease/disorder
  • Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
  • Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

  • Heavy exercise within the past 7 days
  • Alcohol intake> 21 units weekly
  • Regular smoker
  • Received experimental drug within 30 days of study entry
  • Planned participation in any experimental study during the study period
  • HIV-Ab, HBsAg and/or HCV Ab positive
  • History of specific allergy
  • Current use of any drug or narcotics.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688012
Other Study ID Numbers  ICMJE SPC3649-201
EudraCT nummer 2008-001012-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joan Drejer/Regulatory Manager, Santaris Pharma
Study Sponsor  ICMJE Santaris Pharma A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Santaris Pharma A/S
Verification Date September 2009

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