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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: SPC3649 Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688012

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PhaseOne Trials, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Santaris Pharma A/S
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Responsible Party: Joan Drejer/Regulatory Manager, Santaris Pharma Identifier: NCT00688012    
Other Study ID Numbers: SPC3649-201
EudraCT nummer 2008-001012-20
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009
Keywords provided by Santaris Pharma A/S:
microRna antagonist
Safety in healthy volunteers
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections