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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: December 11, 2009
Last updated: September 16, 2010
Last verified: September 2010
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.

Condition Intervention Phase
Pharmacology, Clinical Radiation: SLV 334 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Percentage excreted in urine and feces [ Time Frame: 16 days ]
  • metabolic profile SLV334 [ Time Frame: 16 days ]
  • AUC, CL, lambda z, Cmax, t1/2, tmax and Vss [ Time Frame: 16 Days ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 16 days ]
  • vital signs [ Time Frame: 16 days ]
  • ECG [ Time Frame: 16 days ]
  • Laboratory safety variables [ Time Frame: 16 days ]
  • Physical examination [ Time Frame: 16 days ]

Enrollment: 6
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SLV 334
Radiation: SLV 334
2000 mg via i.v. solution


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc > 430 ms; positive drug screen
  Contacts and Locations
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Please refer to this study by its identifier: NCT01044524

S334.1.004 - Site 1
Zuid-Laren, Netherlands
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Anita Vanderlaan Abbott Products
  More Information Identifier: NCT01044524     History of Changes
Other Study ID Numbers: S334.1.004
2009-017406-37 ( EudraCT Number )
01044524 ( Other Grant/Funding Number: NCT/NIH )
Study First Received: December 11, 2009
Last Updated: September 16, 2010

Keywords provided by Solvay Pharmaceuticals:
14C labeled ADME (Aborption Distribution Metabolism and Elimination) study
Phase I processed this record on August 22, 2017