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

ClinicalTrials.gov ID: NCT01380561

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT01380561
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Tioga Pharmaceuticals; Industry
Enrollment: 6 participants

Conditions and interventions

Conditions

Healthy

Interventions

asimadoline Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 56 Years
Sex: Male
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2011 (Type not available)
Primary completion: Jul 2011 (Actual)
Completion: Jul 2011 (Actual)
Last update posted: Oct 18, 2011

2011

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Quintiles Phase 1 Unit	Overland Park	Kansas	66211	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01380561, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 18, 2011 · Synced Nov 15, 2026