NCT02578082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

October 8, 2015

Last Update Submit

February 22, 2022

Conditions

Renal Impairment

Keywords

Renal ImpairmentRenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse Events (AE)

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

Study Arms (2)

Renal Impairment

EXPERIMENTAL

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

Drug: TD-4208

Normal Renal Function

EXPERIMENTAL

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

Drug: TD-4208

Interventions

TD-4208DRUG

A single inhaled dose of TD 4208 (175 mcg)

Also known as: revefenacin
Normal Renal FunctionRenal Impairment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

Location

Related Publications (1)

  • 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.

    PMID: 31632000DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

revefenacin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 16, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)