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Safety Study of SPC3649 in Healthy Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688012
First Posted: June 2, 2008
Last Update Posted: September 18, 2009
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.
Information provided by:
Santaris Pharma A/S
  Purpose
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 Intervention Phase
Hepatitis C Drug: SPC3649 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Santaris Pharma A/S:

Estimated Enrollment: 64
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00688012


Locations
Denmark
PhaseOne Trials, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Santaris Pharma A/S
  More Information

Responsible Party: Joan Drejer/Regulatory Manager, Santaris Pharma
ClinicalTrials.gov Identifier: NCT00688012     History of Changes
Other Study ID Numbers: SPC3649-201
EudraCT nummer 2008-001012-20
First Submitted: May 7, 2008
First Posted: June 2, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Santaris Pharma A/S:
antisense
microRna antagonist
anti-miR-122
Safety in healthy volunteers
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections