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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
 Drug: SLV337 suspension
Drug: SLV337 capsule
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
400 mg suspension
 Drug: SLV337 suspension
400 mg experimental
Active Comparator: B
5 x 200 mg immediate release capsule
 Drug: SLV337 capsule
5 x 200 mg immediate release capsule

Detailed Description:

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

  Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

  • Seizures,
  • Orthostatic hypotension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176201

Locations
Netherlands
Site Reference ID/Investigator# 61345
Zuidlaren, Netherlands, 9370 AE
Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Anita Vanderlaan Abbott Healthcare Products BV
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT01176201     History of Changes
Other Study ID Numbers: S337.1.005, 2010-020006-15
Study First Received: July 20, 2010
Last Updated: August 25, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Abbott:
SLV337
Diabetes
Relative bioavailability
ADME

ClinicalTrials.gov processed this record on May 22, 2013