Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Study Overview
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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 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.

Official Title
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The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: TD-4208


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Impairment<br>Eight subjects with Severe Renal Impairment (eGFR <30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose. | Drug: TD-4208<br>* A single inhaled dose of TD 4208 (175 mcg)<br>* Other names: revefenacin;|
| Experimental: Normal Renal Function<br>Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose. | Drug: TD-4208<br>* A single inhaled dose of TD 4208 (175 mcg)<br>* Other names: revefenacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | TD-4208 Cmax derived from plasma concentration-time curves | Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From the time of study drug administration through the end of the study (Day 5 or early termination) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency, Renal Impairment