Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578082
• Other study ID #: 0135
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• TD-4208
A single inhaled dose of TD 4208 (175 mcg)

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center (OCRC)	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From the time of study drug administration through the end of the study (Day 5 or early termination)