Skip to main content
OpenTrials
Completed

NCT Number: NCT02581592

Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Impairment Digestive System Diseases Fibrosis Hepatitis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center (OCRD)

Orlando, Florida, 32809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TD-4208

Drug

A single inhaled dose of TD 4208 (175 mcg)

Other names: revefenacin

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: 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 outcomes

  1. Adverse Events (AE)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2015
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.