Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mylan Inc.; Theravance Biopharma R & D, Inc.
• Collaborator: Theravance Biopharma

Criteria

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.