- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02578082
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
February 22, 2022 updated by: Mylan Inc.
The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Orlando, Florida, United States, 32809
- Orlando Clinical Research Center (OCRC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal Impairment
Eight subjects with Severe Renal Impairment (eGFR <30 mL/min/1.73m2).
Intervention is TD-4208, 175mcg, inhaled, single dose.
|
A single inhaled dose of TD 4208 (175 mcg)
Other Names:
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Experimental: Normal Renal Function
Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose. |
A single inhaled dose of TD 4208 (175 mcg)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed plasma concentration (Cmax)
Time Frame: Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
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TD-4208 Cmax derived from plasma concentration-time curves
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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)
Time Frame: From the time of study drug administration through the end of the study (Day 5 or early termination)
|
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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 8, 2015
First Submitted That Met QC Criteria
October 15, 2015
First Posted (Estimate)
October 16, 2015
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 22, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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JW PharmaceuticalCompletedHealthy, Renal ImpairmentKorea, Republic of
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Idorsia Pharmaceuticals Ltd.CompletedHealthy Subjects | Severe Renal ImpairmentCzechia
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