Renal Impairment
Conditions
Keywords
Renal Impairment, Renal Insufficiency
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.
Interventions
DRUGTD-4208
A single inhaled dose of TD 4208 (175 mcg)
Sponsors
Theravance Biopharma
Mylan Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose | TD-4208 Cmax derived from plasma concentration-time curves |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | 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 |
Countries
United States
Outcome results
None listed