Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hepatic Impairment

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

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

A single inhaled dose of TD 4208 (175 mcg)

Normal Hepatic Function

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

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

A single inhaled dose of TD 4208 (175 mcg)

Interventions

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TD-4208

A single inhaled dose of TD 4208 (175 mcg)

Intervention Type DRUG

Other Intervention Names

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revefenacin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes