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Clinical Trials associated with SK-1404A phase II randomized double blind placebo-controlled parallel-group multicenter study of KRP-N118 in patients with Nocturia due to nocturnal polyuria
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1404 Administered to Healthy Male Subjects
The primary objectives of the study are:
* To determine the absolute bioavailability of SK-1404
* To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
* To provide plasma, urine and faecal samples for metabolite profiling and structural identification
The secondary objectives of the study are:
* To determine the routes and rates of elimination of [14C]-SK-1404
* To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
* To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404
* To further explore the PO PK of SK-1404
* To provide additional safety and tolerability information for SK-1404
100 Clinical Results associated with SK-1404
100 Translational Medicine associated with SK-1404
100 Patents (Medical) associated with SK-1404
100 Deals associated with SK-1404