Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

Mylan

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02578082

0135

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Renal Impairment

Experimental group

Description:

Eight subjects with Severe Renal Impairment (eGFR \<30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose.

Treatment:

Drug: TD-4208

Normal Renal Function

Experimental group

Description:

Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose.

Treatment:

Drug: TD-4208