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An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.
For the renal and hepatic subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 2 nights and 2 days. Study drug administration will occur on Study Day 1. Subjects will be discharged on Study Day 2 after the last blood sample has been collected. Subjects will return 7 ± 3 days after dosing with study drug to have final safety assessments performed. For the healthy subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 3 nights and 3 days. Study drug administration will occur on Study Day 1 and Study Day 2. Subjects will be discharged on Study Day 3 after the last blood sample has been collected. Subjects will return 7 ± 3 days after receiving the last dose of study drug to have final safety assessments performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sporanox | Active Comparator | Active arm approved as an anti-fungal being used to compare HPβCD when administered in DIC075V compared to Sporanox. |
|
| Dyloject | Experimental | Diclofenac Sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sporanox | Drug | 200 mg |
| |
| Diclofenac Sodium |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and pharmacokinetics of diclofenac and HPβCD following a single-dose of DIC075V in subjects with mild or moderate chronic renal insufficiency and in subjects with mild hepatic impairment compared to healthy adult volunteers. | Screening - Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and pharmacokinetics of HPβCD following a single-dose of DIC075V and Sporanox in healthy adult volunteers. | Screening - Follow-up |
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Inclusion Criteria (General):
Inclusion Criteria (subjects with mild or moderate chronic renal insufficiency):
Inclusion Criteria (subjects with mild chronic hepatic impairment):
Inclusion Criteria (for healthy subjects):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Smith, MD | New Orleans Clinical Center for Research | Principal Investigator |
| Suzanne Swann, MD | Davita Clinical Research | Principal Investigator |
| Thomas Marbury, MD | Orlando Clinical Research Center | Principal Investigator |
| Salvatore Febbraro, MD | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| Davita Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29197175 | Derived | Hamilton DA, Ernst CC, Kramer WG, Madden D, Lang E, Liao E, Lacouture PG, Ramaiya A, Carr DB. Pharmacokinetics of Diclofenac and Hydroxypropyl-beta-Cyclodextrin (HPbetaCD) Following Administration of Injectable HPbetaCD-Diclofenac in Subjects With Mild to Moderate Renal Insufficiency or Mild Hepatic Impairment. Clin Pharmacol Drug Dev. 2018 Feb;7(2):110-122. doi: 10.1002/cpdd.417. Epub 2017 Dec 2. |
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| Drug |
37.5 mg |
|
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| New Orleans Clinical Center for Research | Knoxville | Tennessee | 37920 | United States |
| Simbec Research, Ltd. | Merthyr Tydfil | CF48 4DR | United Kingdom |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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