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

Phase 1

Completed

• Conditions: Pharmacology, Clinical
• Interventions: Radiation: SLV 334

• Registration Number: NCT01044524
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Study Start: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SLV 334	SLV 334

Primary Outcome Measures

Name	Time	Method
Percentage excreted in urine and feces	16 days
AUC, CL, lambda z, Cmax, t1/2, tmax and Vss	16 Days
metabolic profile SLV334	16 days

Secondary Outcome Measures

Name	Time	Method
vital signs	16 days
Laboratory safety variables	16 days
Physical examination	16 days
ECG	16 days
adverse events	16 days

Trial Locations

Locations (1)

S334.1.004 - Site 1; 🇳🇱 Zuid-Laren, Netherlands