Safety Study of SPC3649 in Healthy Men

NCT ID: NCT00688012

Last Updated: 2009-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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SPC3649

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Santaris Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Santaris Pharma

Locations

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PhaseOne Trials, Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EudraCT nummer 2008-001012-20

Identifier Type: -

Identifier Source: secondary_id

SPC3649-201

Identifier Type: -

Identifier Source: org_study_id

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