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Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

NCT02578082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-02-24

No results posted yet for this study

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.

Conditions

  • Renal Impairment

Interventions

DRUG

TD-4208

A single inhaled dose of TD 4208 (175 mcg)

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578082 on ClinicalTrials.gov