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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044524
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : September 17, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pharmacology, Clinical Radiation: SLV 334 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: 1
SLV 334
Radiation: SLV 334
2000 mg via i.v. solution

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

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 16 days ]
  2. vital signs [ Time Frame: 16 days ]
  3. ECG [ Time Frame: 16 days ]
  4. Laboratory safety variables [ Time Frame: 16 days ]
  5. Physical examination [ Time Frame: 16 days ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044524

S334.1.004 - Site 1
Zuid-Laren, Netherlands
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Anita Vanderlaan Abbott Products Identifier: NCT01044524     History of Changes
Other Study ID Numbers: S334.1.004
2009-017406-37 ( EudraCT Number )
01044524 ( Other Grant/Funding Number: NCT/NIH )
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

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