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
  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
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: 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 October 22, 2014