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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Impairment | Experimental | Eight subjects with Severe Renal Impairment (eGFR <30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose. |
|
| Normal Renal Function | Experimental | Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-4208 | Drug | A single inhaled dose of TD 4208 (175 mcg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | TD-4208 Cmax derived from plasma concentration-time curves | Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | An AE is any unfavorable and unintended change in the body temporally associated with study drug administration, whether or not considered related to the study drug | From the time of study drug administration through the end of the study (Day 5 or early termination) |
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Inclusion Criteria:
For renal impairment group:
For normal renal function group:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center (OCRC) | Orlando | Florida | 32809 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31632000 | Derived | Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C583570 | revefenacin |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |