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Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TD-4208

About this trial

This is an interventional basic science trial for Renal Impairment focused on measuring Renal Impairment, Renal Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Orlando Clinical Research Center (OCRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Renal Impairment

Normal Renal Function

Arm Description

Eight subjects with Severe Renal Impairment (eGFR <30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose.

Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose.

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)

TD-4208 Cmax derived from plasma concentration-time curves

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02578082

First Posted

October 8, 2015

Last Updated

February 22, 2022

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02578082

Brief Title

Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

Renal Impairment, Renal Insufficiency

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Impairment

Arm Type

Experimental

Arm Description

Eight subjects with Severe Renal Impairment (eGFR <30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose.

Arm Title

Normal Renal Function

Arm Type

Experimental

Arm Description

Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose.

Intervention Type

Drug

Intervention Name(s)

TD-4208

Other Intervention Name(s)

revefenacin

Intervention Description

A single inhaled dose of TD 4208 (175 mcg)

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax)

Description

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 Outcome Measure Information:

Title

Adverse Events (AE)

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Orlando Clinical Research Center (OCRC)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31632000

Citation

Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019.

Results Reference

derived

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Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

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