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

August 25, 2011 updated by: Abbott Products

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zuidlaren, Netherlands, 9370 AE
        • Site Reference ID/Investigator# 61345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria

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

Exclusion Criteria

  • Seizures,
  • Orthostatic hypotension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Part 1: 5 days Part 2: 8 days
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
Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)
Time Frame: Part 2: 8 days
Part 2: 8 days
Total 14C-radioactivity (Part 2)
Time Frame: Part 2: 8 days
Part 2: 8 days
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
Part 2: 8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Part 1: 19 days Part 2: 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Products

Investigators

  • Study Director: Anita Vanderlaan, Abbott Healthcare Products BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (ESTIMATE)

August 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S337.1.005
  • 2010-020006-15 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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