NCT01380561

A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers

A Metabolite Identification, Mass Balance, and Pharmacokinetic Study of a Single Oral Dose of [14C]-Asimadoline Followed by Twice Daily Oral Dosing of 0.5 mg Asimadoline to Healthy Adult Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tioga Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

Summary

This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.

Detailed description

This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers. The purposes of this study is to determine the excretion of total \[14C\] derived radioactivity and the metabolite profile after a single oral dose of \[14C\] asimadoline as well as to identify and quantitate the metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	asimadoline	10mg \[14\]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-27
• Last updated: 2011-10-18

Locations

1 site across 1 country: United States