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Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers

NCT ID: NCT00885989

Last Updated: 2010-01-29

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-12-31

Brief Summary

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This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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SLV338 phase I healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

SLV338

Intervention Type DRUG

5 - 1000 mg IV

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SLV338

5 - 1000 mg IV

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy

Exclusion Criteria

* not healthy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 1

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2008-006753-40

Identifier Type: -

Identifier Source: secondary_id

S338.1.002

Identifier Type: -

Identifier Source: org_study_id