Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Mylan Inc. (Industry)
Overall Status
Completed ID
Theravance Biopharma (Industry)
Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Actual Enrollment :
16 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Experimental: Hepatic Impairment

Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose.

Drug: TD-4208
A single inhaled dose of TD 4208 (175 mcg)
Other Names:
  • revefenacin
  • Experimental: Normal Hepatic Function

    Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose.

    Drug: TD-4208
    A single inhaled dose of TD 4208 (175 mcg)
    Other Names:
  • revefenacin
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose]

      TD-4208 Cmax, derived from plasma concentration-time curves

    Secondary Outcome Measures

    1. Adverse Events (AE) [From the time of study drug administration through the end of the study (Day 5 or early termination)]

      An AE is any unfavorable and unintended change in the body temporally associated with study drug administration, whether or not considered related to the study drug

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)

    • For normal hepatic function group: Subject is in good health

    Exclusion Criteria:
    • Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.

    • Subject has received an investigational drug (or medical device) within 30 days

    • Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1Orlando Clinical Research Center (OCRD)OrlandoFloridaUnited States32809

    Sponsors and Collaborators

    • Mylan Inc.
    • Theravance Biopharma


    • Study Director: Medical Monitor, Theravance Biopharma

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Mylan Inc. Identifier:
    Other Study ID Numbers:
    • 0134
    First Posted:
    Oct 21, 2015
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Keywords provided by Mylan Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2022