Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/26/2018 |
| Start Date: | December 2015 |
| End Date: | May 2016 |
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.
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.
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.
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