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Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

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

NCT02578082•Mylan Inc.

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

December 1, 2015

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

February 24, 2022

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

TD-4208

DRUG

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

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Renal Impairment

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ACTIVE_NOT_RECRUITINGPHASE1

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure