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Completed

NCT Number: NCT01176201

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

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.

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Key information

Conditions

Healthy Subjects Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 61345

Zuidlaren, 9370 AE, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Seizures,
  • Orthostatic hypotension

Treatment and study plan

SLV337 suspension

Drug

400 mg experimental

SLV337 capsule

Drug

5 x 200 mg immediate release capsule

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Registry information

Official study title

An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 5, 2010
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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