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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004468-24 | EudraCT Number |
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe renal impairment compared with subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6124, single dose | Experimental | Single dose, Tablet, single administration, Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: EVP-6124 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe renal impairment compared with subjects with normal renal function. | Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, Total area under the plasma concentration time curve from time t to time infinity and Renal clearance of EVP-6124 and metabolites [Time Frame 0-288 hours postdose] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of oral EVP-6124 in subjects with mild, moderate and severe renal impairment and in subjects with normal renal function. | Adverse events, serious adverse events, and concomitant medications will be continuously monitored starting after the time of informed consent through the safety follow-up visit. Assessments will be made via recording of adverse events, concomitant medications, laboratory safety tests, vital signs, 12-lead ECGs and physical examinations. |
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Inclusion Criteria:
Adult male or female subjects age 18 to 70 years (both inclusive).
Able to understand and willing to sign the Informed Consent Form and able to comply with the study restrictions.
Females may enroll if they are:
Males with partners of childbearing potential may be enrolled if they are:
BMI 18.0 - 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2).
Medical history, ECG, vital signs, and the results of biochemistry, coagulation and hematology tests and urinalysis) carried out at Screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jankovcova 1569/2c, 17000 Praha 7 | Czechia | |||||
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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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| Day 1 to Day 13 or Early Termination |
| Rottenbiller U. 13 H-1077 Budapest |
| Hungary |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |