Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 24, 2022
February 1, 2022
5 months
October 19, 2015
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum observed plasma concentration (Cmax)
TD-4208 Cmax, derived from plasma concentration-time curves
Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
Secondary Outcomes (1)
Adverse Events (AE)
From the time of study drug administration through the end of the study (Day 5 or early termination)
Study Arms (2)
Hepatic Impairment
EXPERIMENTALEight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose.
Normal Hepatic Function
EXPERIMENTALEight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose.
Interventions
A single inhaled dose of TD 4208 (175 mcg)
Eligibility Criteria
You may qualify if:
- For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
- For normal hepatic function group: Subject is in good health
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
- Theravance Biopharmacollaborator
Study Sites (1)
Orlando Clinical Research Center (OCRD)
Orlando, Florida, 32809, United States
Related Publications (1)
Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019.
PMID: 31632000DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 21, 2015
Study Start
November 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share