Safety Study of SPC3649 in Healthy Men

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688012
• Other study ID #: SPC3649-201
• Secondary ID: EudraCT nummer 2
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2008
• Last updated: September 17, 2009
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• SPC3649

Locations

Country	Name	City	State
Denmark	PhaseOne Trials, Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Denmark,