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14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT01176201
First received: July 20, 2010
Last updated: August 25, 2011
Last verified: August 2011

July 20, 2010
August 25, 2011
July 2010
October 2010   (final data collection date for primary outcome measure)
  • AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2) [ Time Frame: Part 1: 5 days Part 2: 8 days ] [ Designated as safety issue: No ]
  • AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2) [ Time Frame: Part 2: 8 days ] [ Designated as safety issue: No ]
  • Excretion balance of total 14C-radioactivity (Part 2) [ Time Frame: Part 2: 8 days ] [ Designated as safety issue: No ]
  • Total 14C-radioactivity (Part 2) [ Time Frame: Part 2: 8 days ] [ Designated as safety issue: No ]
  • Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2) [ Time Frame: Part 2: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01176201 on ClinicalTrials.gov Archive Site
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2) [ Time Frame: Part 1: 19 days Part 2: 15 days ] [ Designated as safety issue: Yes ]
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2). [ Time Frame: Part 1: 19 days Part 2: 15 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension

This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
  • Drug: SLV337 suspension
    400 mg experimental
  • Drug: SLV337 capsule
    5 x 200 mg immediate release capsule
  • Experimental: A
    400 mg suspension
    Intervention: Drug: SLV337 suspension
  • Active Comparator: B
    5 x 200 mg immediate release capsule
    Intervention: Drug: SLV337 capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria

  • BMI 18 - 28 kg/m2
  • SBP 90-140
  • DBP 50-90

Exclusion Criteria

  • Seizures,
  • Orthostatic hypotension
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01176201
S337.1.005, 2010-020006-15
No
Abbott ( Abbott Products )
Abbott Products
Not Provided
Study Director: Anita Vanderlaan Abbott Healthcare Products BV
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP