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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014