Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: TD-4208

• Registration Number: NCT02581592
• Lead Sponsor: Mylan Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2015-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatic Impairment	TD-4208	Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose.
Normal Hepatic Function	TD-4208	Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orlando Clinical Research Center (OCRD); 🇺🇸 Orlando, Florida, United States