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Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-4208
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring Hepatic Impairment, Hepatitis, Liver Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Orlando Clinical Research Center (OCRD)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hepatic Impairment

Normal Hepatic Function

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)
TD-4208 Cmax, derived from plasma concentration-time curves

Secondary Outcome Measures

Adverse Events (AE)
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

Full Information

First Posted
October 19, 2015
Last Updated
February 22, 2022
Sponsor
Mylan Inc.
Collaborators
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT02581592
Brief Title
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
Official Title
The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
Theravance Biopharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Hepatic Impairment, Hepatitis, Liver Cirrhosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatic Impairment
Arm Type
Experimental
Arm Description
Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose.
Arm Title
Normal Hepatic Function
Arm Type
Experimental
Arm Description
Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose.
Intervention Type
Drug
Intervention Name(s)
TD-4208
Other Intervention Name(s)
revefenacin
Intervention Description
A single inhaled dose of TD 4208 (175 mcg)
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
TD-4208 Cmax, derived from plasma concentration-time curves
Time Frame
Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
Secondary Outcome Measure Information:
Title
Adverse Events (AE)
Description
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
Time Frame
From the time of study drug administration through the end of the study (Day 5 or early termination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center (OCRD)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31632000
Citation
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.
Results Reference
derived

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Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

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