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Following multiple-dose administration of telotristat ethyl 500 mg three times daily, there was negligible accumulation at steady state for both telotristat ethyl and telotristat. In patients with metastatic neuroendocrine tumors and carcinoid syndrome diarrhea treated with SSA therapy, the median T max for telotristat ethyl and telotristat was approximately 1 and 2 hours, respectively. Following administration of 500 mg telotristat ethyl three times daily, with meals in patients, the mean C max and AUC 0-6hr were approximately 7 ng/mL and 22 ng’hr/mL, respectively, for telotristat ethyl. The mean C max and AUC 0-6hr were approximately 900 ng/mL and 3000 ng’hr/mL, respectively for telotristat. The pharmacokinetic parameters for both telotristat ethyl and telotristat were highly variable with about 55% coefficient of variation. Administration of a single 500 mg dose of Xermelo (twice the recommended dose) with food resulted in higher exposure to both telotristat ethyl and telotristat. The systemic exposure to telotristat ethyl, was significantly increased following administration with a high-fat meal, with C max , and AUC 0-inf being 112%, and 264% higher, respectively compared to the fasted state. Following administration of a single 500 mg dose of telotristat ethyl under the fed conditions in healthy subjects, the mean C max and AUC 0-inf were 10. The C max and AUC 0-inf values for telotristat were also increased by 47% and 33%, respectively, with a high-fat meal compared to the fasted state. The mean C max and AUC 0-inf were 908 ng/mL and 2980 ng’hr/mL, respectively for telotristat under the fed condition. Both telotristat ethyl and telotristat are greater than 99% bound to human plasma proteins. In vitro data suggests that telotristat is a substrate of P-glycoprotein. Following a single 500 mg oral dose of telotristat ethyl in healthy subjects, the apparent half-life was approximately 0. The apparent total clearance at steady state (CL/F ss ) following oral dosing with telotristat ethyl 500 mg three times daily for 14 days (twice the recommended dosage) in healthy subjects was 2. After oral administration, telotristat ethyl undergoes hydrolysis via carboxylesterases to telotristat, its active metabolite. Telotristat is further metabolized. Among the metabolites of telotristat, the systemic exposure to an acid metabolite of oxidative deaminated decarboxylated telotristat was about 35% of that of telotristat. In vitro data suggest that telotristat ethyl and telotristat are not substrates for CYP enzymes. Following a single 500 mg oral dose of 14 C-telotristat ethyl, 93. Population pharmacokinetic analysis indicated that age (18 to 83 years) and sex do not affect the pharmacokinetics of telotristat. Population pharmacokinetic analysis indicated that creatinine clearance (20 to 89 mL/min) does not affect the pharmacokinetics of telotristat. Xermelo was not studied in end-stage renal disease (ESRD) patients who require dialysis. Population pharmacokinetic analysis indicated that mild hepatic impairment (defined as total bilirubin greater than 1 to 1. The effect of moderate or severe hepatic impairment (defined as total bilirubin greater than 1. Effect of Telotristat Ethyl on Other Drugs, legal steroids philippines.
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