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TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

NCT02772159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-02-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of an investigational medication used to treat chronic obstructive pulmonary disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a 28 day washout period between each of the 2 dosing routes.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

TD-4208

One dose each of treatments A: \[14C\] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: \[14C\] TD-4208 200 μg oral solution administered in a fasted state.

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma, US, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02772159 on ClinicalTrials.gov