Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Mylan Inc.16 enrolled

Overview

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

TD-4208DRUG

A single inhaled dose of TD 4208 (175 mcg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For renal impairment group: * Subject has severe renal impairment (eGFR \<30 mL/min/1.73 m2) For normal renal 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.

Locations (1)

Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax)

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 Outcomes

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

Time frame: From the time of study drug administration through the end of the study (Day 5 or early termination)

Data from ClinicalTrials.gov

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