Trials / Completed
CompletedNCT02578082
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Mylan Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TD-4208 | A single inhaled dose of TD 4208 (175 mcg) |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2015-10-16
- Last updated
- 2022-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02578082. Inclusion in this directory is not an endorsement.