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

NCT01380561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2011-10-18

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Tioga Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Dr. Philip Leese · Quintiles Phase 1 Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01380561 on ClinicalTrials.gov