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Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion

NCT ID: NCT01044524

Last Updated: 2010-09-17

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.

Detailed Description

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Conditions

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Pharmacology, Clinical

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

SLV 334

Group Type EXPERIMENTAL

SLV 334

Intervention Type RADIATION

2000 mg via i.v. solution

Interventions

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SLV 334

2000 mg via i.v. solution

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc \> 430 ms; positive drug screen
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

Principal Investigators

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Anita Vanderlaan

Role: STUDY_DIRECTOR

Abbott Products

Locations

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S334.1.004 - Site 1

Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2009-017406-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

01044524

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S334.1.004

Identifier Type: -

Identifier Source: org_study_id