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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. The potential for telotristat ethyl and telotristat to induce CYP enzymes (1A2 and 2B6) or inhibit CYP enzymes (2B6, 2C8, and 2C9) has not been adequately studied in vitro. In vitro telotristat ethyl inhibited P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP), but telotristat did not inhibit P-gp and BCRP at the clinically relevant concentrations. However, in vivo drug interaction potential via inhibition of BCRP is low based on in vitro studies and in vivo findings. Based on in vitro studies, in vivo drug interaction potential via inhibition of organic cation transporter 1 (OCT1), OCT2, organic anion transporter 1 (OAT1), OAT3, organic anion transporting polypeptide 1B1 (OATP1B1), OATP1B3, or bile salt export pump (BSEP) transporters by telotristat ethyl and telotristat is low at the recommended dosage, gp mast 200 mg injectable steroids $87.00 masteron. Midazolam (sensitive CYP3A4 substrate) Following administration of multiple doses of telotristat ethyl, the systemic exposure to concomitant midazolam was significantly decreased. When 3 mg midazolam was co-administered orally after 5 day treatment with telotristat ethyl 500 mg three times daily (twice the recommended dosage), the mean C max , and AUC 0-inf for midazolam were decreased by 25%, and 48%, respectively, compared to administration of midazolam alone. The mean C max , and AUC 0-inf for the active metabolite, 1′-hydroxymidazolam, were also decreased by 34%, and 48%, respectively. The reduction in the systemic exposure to both midazolam and its active metabolite suggests that the glucuronidation of 1′-hydroxymidazolam may have been increased by telotristat ethyl [see Drug Interactions (7. Fexofenadine (sensitive P-gp substrate) The C max and AUC of fexofenadine increased by 16% when a single 180 mg dose of fexofenadine was co-administered orally with the final dose of telotristat ethyl 500 mg administered three times daily (twice the recommended dosage) for 5 days. Clinically meaningful interactions with P-gp substrates are unlikely. Effect of Other Drugs on Telotristat Ethyl. The mean C max and AUC 0-last of telotristat ethyl were decreased by 86% and 81%, respectively, following administration of a single 500 mg dose of Xermelo (twice the recommended dose), co-administered with short-acting octreotide 200 mcg injected subcutaneously in healthy subjects. The mean C max and AUC 0-last of telotristat were decreased by 79% and 68%, respectively [see Clinical Studies (14)]. Carcinogenesis, Mutagenesis, Impairment of Fertility. In a 26-week study in transgenic (Tg. undefined Gp mast 200 mg geneza pharmaceuticals $87. 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