Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Mylan

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581592

0134

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: TD-4208

Normal Hepatic Function

Experimental group

Description:

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

Treatment:

Drug: TD-4208