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

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ClinicalTrials.gov Identifier: NCT01176201
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Drug: SLV337 suspension Drug: SLV337 capsule Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Excretion balance of total 14C-radioactivity (Part 2) [ Time Frame: Part 2: 8 days ]
  4. Total 14C-radioactivity (Part 2) [ Time Frame: Part 2: 8 days ]
  5. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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
Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Seizures,
  • Orthostatic hypotension

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT01176201     History of Changes
Other Study ID Numbers: S337.1.005
2010-020006-15 ( EudraCT Number )
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
SLV337
Diabetes
Relative bioavailability
ADME