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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02581592

Enrollment

Registered

2015-10-21

Start date

2015-11-30

Completion date

2016-04-30

Last updated

2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment, Hepatitis, Liver Cirrhosis

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.

Interventions

DRUGTD-4208

A single inhaled dose of TD 4208 (175 mcg)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026