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10.1111/bcp.12380

http://scihub22266oqcxt.onion/10.1111/bcp.12380
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suck abstract from ncbi


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pmid24628035
      Br+J+Clin+Pharmacol 2014 ; 78 (3 ): 498-508
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  • Tolerability, pharmacokinetics and pharmacodynamics of TA-8995, a selective cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects #MMPMID24628035
  • Ford J ; Lawson M ; Fowler D ; Maruyama N ; Mito S ; Tomiyasu K ; Kinoshita S ; Suzuki C ; Kawaguchi A ; Round P ; Boyce M ; Warrington S ; Weber W ; van Deventer S ; Kastelein JJ
  • Br J Clin Pharmacol 2014[Sep]; 78 (3 ): 498-508 PMID24628035 show ga
  • AIMS: Two double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects. METHODS: Study 1: Subjects received single doses of TA-8995 or placebo (fasted). Doses were 5, 10, 25, 50 (fed/fasted), 100 and 150?mg (Caucasian males, 18-55?years), 25?mg (Caucasian males, > 65?years and Caucasian females, 18-55?years), 25, 50, 100 and 150?mg (Japanese males, 18-55?years). Study 2: Caucasian males (18-55?years) received 1, 2.5, 10 or 25?mg once daily TA-8995 or placebo for 21-28?days. Blood and urine for pharmacokinetics and/or pharmacodynamics were collected. Tolerability was assessed by adverse events, vital signs, electrocardiograms and laboratory safety tests. RESULTS: Peak TA-8995 concentrations occurred approximately 4?h post-dose. Mean half-lives ranged from 81 to 166?h, without an obvious dose relationship. Exposure increased less than proportionally to dose. TA-8995 was not excreted in urine. Following 2.5 to 25?mg once daily dosing, TA-8995 demonstrated nearly complete inhibition of CETP activity (92-99%), increased high density lipoprotein-cholesterol (HDL-C) by 96 to 140% and decreased low density liporotein-cholesterol (LDL-C) by 40% to 53%. There were dose-related increases in apolipoproteins A-1 and E, HDL2-C and HDL3-C, and decreases in apolipoprotein B and lipoprotein A. There was no evidence of significant effects of age, gender, ethnicity or food on pharmacokinetics or pharmacodynamics. All doses were well tolerated. CONCLUSIONS: TA-8995 is a potent CETP inhibitor and warrants further investigation.
  • |*Asian People [MESH]
  • |*White People [MESH]
  • |Adolescent [MESH]
  • |Adult [MESH]
  • |Cholesterol Ester Transfer Proteins/*antagonists & inhibitors [MESH]
  • |Cholesterol, HDL/blood [MESH]
  • |Cholesterol, LDL/blood [MESH]
  • |Dose-Response Relationship, Drug [MESH]
  • |Double-Blind Method [MESH]
  • |Electrocardiography [MESH]
  • |Female [MESH]
  • |Half-Life [MESH]
  • |Humans [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Quinolines/*administration & dosage/pharmacokinetics/pharmacology [MESH]


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