Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT02578082

Run by

Mylan Inc.

People needed

16

Starts

2015-12-01

Expected to finish

2016-05-01

Last updated by the study team

2022-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Orlando Clinical Research Center (OCRC) — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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