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NCT01044524 Clinical Trial

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

Pharmacology, Clinical Clinical Trial

Official title:
An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01044524
Other study ID # S334.1.004
Secondary ID 2009-017406-3701
Status Completed
Phase Phase 1
First received December 11, 2009
Last updated September 16, 2010
Start date February 2010
Est. completion date March 2010

Study information
Verified date September 2010
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc > 430 ms; positive drug screen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• SLV 334
2000 mg via i.v. solution

Locations
Country Name City State
Netherlands S334.1.004 - Site 1 Zuid-Laren

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage excreted in urine and feces 16 days No
Primary metabolic profile SLV334 16 days No
Primary AUC, CL, lambda z, Cmax, t1/2, tmax and Vss 16 Days No
Secondary adverse events 16 days Yes
Secondary vital signs 16 days Yes
Secondary ECG 16 days Yes
Secondary Laboratory safety variables 16 days Yes
Secondary Physical examination 16 days Yes
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