Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Sponsor
Mylan Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02581592
Collaborator
Theravance Biopharma (Industry)
16
Enrollment
1
Location
2
Arms
5
Duration (Months)
3.2
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:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
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

ArmIntervention/Treatment
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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

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

    Sponsors and Collaborators

    • Mylan Inc.
    • Theravance Biopharma

    Investigators

    • Study Director: Medical Monitor, Theravance Biopharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mylan Inc.
    ClinicalTrials.gov Identifier:
    NCT02581592
    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:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mylan Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2022