SPC3649 Multiple Dose Study in Healthy Volunteers

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. Identifier: NCT00979927
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):
Santaris Pharma A/S

September 17, 2009
September 18, 2009
October 5, 2011
September 2009
September 2010   (Final data collection date for primary outcome measure)
Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ]
Not Provided
Complete list of historical versions of study NCT00979927 on Archive Site
  • Peak Plasma Concentration (Cmax) of SPC3649 [ Time Frame: Up to 169 Days ]
  • Effect on total Cholesterol [ Time Frame: Up to 169 Days ]
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SPC3649 Multiple Dose Study in Healthy Volunteers
A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: SPC3649
    5 weekly doses
  • Drug: saline
    5 weekly doses
  • Placebo Comparator: Saline
    Intervention: Drug: saline
  • Active Comparator: SPC3649
    Intervention: Drug: SPC3649
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Eudract no 2009-012153-38
Not Provided
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Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Salah Hadi, MD,MSc PRA Health Sciences
Santaris Pharma A/S
October 2011

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