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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01044524
First received: December 11, 2009
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • metabolic profile SLV334 [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • AUC, CL, lambda z, Cmax, t1/2, tmax and Vss [ Time Frame: 16 Days ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044524

Locations
Netherlands
S334.1.004 - Site 1
Zuid-Laren, Netherlands
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Anita Vanderlaan Abbott Products
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01044524     History of Changes
Other Study ID Numbers: S334.1.004, 2009-017406-37, 01044524
Study First Received: December 11, 2009
Last Updated: September 16, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Solvay Pharmaceuticals:
14C labeled ADME (Aborption Distribution Metabolism and Elimination) study
Phase I

ClinicalTrials.gov processed this record on May 16, 2013