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This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.
Following Screening, enrolled participants will be confined to a clinical research unit for 6 days. Each participant will receive a single oral dose of clofutriben. Clofutriben PK, safety, and tolerability will be assessed. The participants will be contacted by telephone 4 weeks after clofutriben administration for safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clofutriben | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12mg clofutriben | Drug | Each participant will receive a single oral dose of clofutriben |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Maximum plasma concentration (Cmax) | Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the [60%, 140%] range. | from enrollment through treatment for 6 days. |
| 2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf) | Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the [60%, 140%] range. | from enrollment through treatment for 6 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
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