- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00688012
Safety Study of SPC3649 in Healthy Men
September 17, 2009 updated by: Santaris Pharma A/S
A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
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 Overview
Study Type
Interventional
Enrollment
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hvidovre, Denmark, DK-2650
- PhaseOne Trials, Hvidovre University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: QUADRUPLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
May 1, 2009
Study Completion (ACTUAL)
May 1, 2009
Study Registration Dates
First Submitted
May 7, 2008
First Submitted That Met QC Criteria
May 30, 2008
First Posted (ESTIMATE)
June 2, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 18, 2009
Last Update Submitted That Met QC Criteria
September 17, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPC3649-201
- EudraCT nummer 2008-001012-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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