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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176201
• Other study ID #: S337.1.005
• Secondary ID: 2010-020006-15
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2010
• Last updated: August 25, 2011
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• BMI 18 - 28 kg/m2

• SBP 90-140

• DBP 50-90

Exclusion Criteria

• Seizures,

• Orthostatic hypotension

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• SLV337 suspension
400 mg experimental
• SLV337 capsule
5 x 200 mg immediate release capsule

Locations

Country	Name	City	State
Netherlands	Site Reference ID/Investigator# 61345	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t, AUC, Cmax, tmax, t1/2, ?z, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)		Part 1: 5 days Part 2: 8 days	No
Primary	AUC0-t, AUC, Cmax, tmax, t1/2, ?z, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)		Part 2: 8 days	No
Primary	Excretion balance of total 14C-radioactivity (Part 2)		Part 2: 8 days	No
Primary	Total 14C-radioactivity (Part 2)		Part 2: 8 days	No
Primary	Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)		Part 2: 8 days	No
Secondary	Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)		Part 1: 19 days Part 2: 15 days	Yes