Description of study population | Methods | Results | References |
---|---|---|---|
Patients with ovarian cancer | Two-way crossover design ((feeding versus fasting) - each subject received 2 separate 300-mg doses of niraparib, 1 each in a fasting and a fed state - investigating pharmacokinetic parameters based on feeding state | - The mean ratios of Cmax and AUC0-inf in the fed (test) versus fasted state (reference) were 0.83 and 1.08, respectively - The mean t1/2 of feeding and fasting states are 57 and 59Â h, respectively - Median Tmax in the feeding condition is almost 2 times to that of fasting state | [45] |
Rodents with BRCA2-mutant (Capan-1) and MDA-MB-436 (BRCA-1 mutant) human pancreatic cancer xenograft model | Randomized cohorts of Balb/c nude mice bearing either subcutaneous Capan-1 tumors, or intracranial Capan-1-luc tumors - Dosing of niraparib (15, 30, or 45 mg/kg QD) - Up to 50 days - Investigating the brain and plasma levels of niraparib | - Similar Concentration-time profiles of niraparib in the brain and plasma - Mean brain-to-plasma concentration ratios for niraparib following a single oral dose to rats were 0.85–0.99 of the brain Tmax - Brain Ctrough levels (24 h) were 2–4 times greater than observed in plasma, indicating niraparib is able to penetrate the brain in rodents - Have therapeutic benefit in an IC BRCA-mutant human xenograft model | [49] |