Safety, pharmacokinetics, and pharmacodynamic effects of a selective TGR5 agonist, SB-756050, in type 2 diabetes.

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Safety, pharmacokinetics, and pharmacodynamic effects of a selective TGR5 agonist, SB-756050, in type 2 diabetes.

Hodge RJ, Lin J, Johnson LSV, Gould EP, Bowers GD, Nunex DJ.

Journal		Clinical Pharmacology in Drug Development
Species
Analytes Measured		GLP-1 , Glucagon , Insulin
Matrix Tested		Plasma

Year		2013
Volume		2
Page Numbers		213-222
Application		Metabolic

Abstract

TGR5 is a bile acid receptor and a potential target for the treatment of type 2 diabetes (T2D). We report here the safety, pharmacokinetics, and pharmacodynamic effects of a selective TGR5 agonist, SB-756050, in patients with T2D. Fifty-one subjects were randomized to receive either placebo or one of four doses of SB-756050 for 6 days. A single 100 mg dose of sitagliptin was co-administered on Day 6 to all subjects. SB-756050 was well-tolerated; it was readily absorbed, exhibited nonlinear pharmacokinetics with a less than dose-proportional increase in plasma exposure above 100 mg, and demonstrated no significant changes in exposure when co-administered with sitagliptin. SB-756050 demonstrated highly variable pharmacodynamic effects both within dose groups and between doses, with increases in glucose seen at the two lowest doses and no reduction in glucose seen at the two highest doses. The glucose effects of SB-756050 + sitagliptin were comparable to those of sitagliptin alone, even though gut hormone plasma profiles were different.

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V-PLEX Custom Human Biomarkers 1 C-Peptide, CRP, Eotaxin, Eotaxin-3, FGF (basic), GIP (active), GLP-1 (active), Glucagon, GM-CSF, ICAM-1, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, Insulin, IP-10, Leptin, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, PP, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1 \| Human Multiplex
V-PLEX Custom NHP Biomarkers 1 C-Peptide, Eotaxin, Eotaxin-3, GIP (active), GLP-1 (active), Glucagon, GM-CSF, IFN-γ, IL-1β, IL-2, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-15, IL-16, IL-17A, Insulin, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PP, TARC, TNF-β, VEGF-A \| Non-human primate Multiplex
U-PLEX Custom Metabolic Group 1 (ms) 384-well Assays BAFF, BCA-1/BLC, BDNF, CD40/TNFRSF5, C-Peptide, Eotaxin, EPO, FGF-21, Ghrelin (active), Ghrelin (total), GLP-1 (active), GLP-1 (inactive), GLP-1 (total), Glucagon, GM-CSF, IFN-α, IFN-β, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17C, IL-17E/IL-25, IL-17F, IL-21, IL-22, IL-23, IL-27p28/IL-30, IL-31, IL-33, Insulin, IP-10, KC/GRO, Leptin, MCP-1, MCP-5/CCL12, MDC, MIP-1α, MIP-1β, MIP-2, MIP-3α, MMP-9 (total), PYY (total), RANTES, TARC, TNF-α, VEGF-A \| Mouse Multiplex
U-PLEX Custom Metabolic Group 1 (rat) 384-well Assays BDNF, C-Peptide, FGF-21, Ghrelin (active), Ghrelin (total), GLP-1 (active), GLP-1 (inactive), GLP-1 (total), Glucagon, Insulin, Leptin, PYY (total) \| Rat Multiplex
U-PLEX Mouse GLP-1 (total) 384-Well Assay GLP-1 (total) \| Mouse Singleplex
U-PLEX Mouse Glucagon 384-Well Assay Glucagon \| Mouse Singleplex
U-PLEX Mouse Insulin 384-Well Assay Insulin \| Mouse Singleplex
U-PLEX Rat GLP-1 (total) 384-Well Assay GLP-1 (total) \| Rat Singleplex
U-PLEX Rat Glucagon 384-Well Assay Glucagon \| Rat Singleplex
U-PLEX Rat Insulin 384-Well Assay Insulin \| Rat Singleplex
U-PLEX Custom Metabolic Group 1 (human) 384-well Assays BAFF, BDNF, β-NGF, C-Peptide, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, EPO, FGF-21, FGF-23, FLT3L, Fractalkine, FSH, G-CSF, Ghrelin (active), Ghrelin (total), GIP (active), GIP (inactive), GIP (total), GLP-1 (active), GLP-1 (inactive), GLP-1 (total), Glucagon, GM-CSF, GRO-α, I-309, IFN-α2a, IFN-β, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-2Rα, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17C, IL-17D, IL-17E/IL-25, IL-17F, IL-18, IL-21, IL-22, IL-23, IL-27, IL-29/IFN-λ1, IL-31, IL-33, Insulin, IP-10, Leptin, Luteinizing Hormone (LH), MCP-1, MCP-2, MCP-4, M-CSF, MDC, MIF, MIP-1α, MIP-5, PP, Proinsulin, PYY (total), SDF-1α, TARC, TNF-α, TNF-β, TPO, TRAIL, TSLP, VEGF-A, YKL-40 \| Human Multiplex
U-PLEX Human GLP-1 (total) 384-well Assay GLP-1 (total) \| Human Singleplex
U-PLEX Human Glucagon 384-well Assay Glucagon \| Human Singleplex
U-PLEX Human Insulin 384-well Assay Insulin \| Human Singleplex
Glucagon Antibody Glucagon \| Human, Mouse, Rat, Non-human primate, Canine
Human Insulin Antibody Insulin \| Human, Non-human primate, Canine
V-PLEX Glucagon Kit Glucagon \| Human, Mouse, Rat, Non-human primate, Canine Singleplex
V-PLEX Human Insulin Kit Insulin \| Human, Non-human primate, Canine Singleplex
V-PLEX Metabolic Panel 1 Canine Kit GIP (active), GLP-1 (active), Glucagon, Insulin \| Canine Multiplex
V-PLEX Metabolic Panel 1 Human Kit C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, Leptin, PP \| Human Multiplex
V-PLEX Metabolic Panel 1 Mouse Kit GLP-1 (active), Glucagon \| Mouse Multiplex
V-PLEX Metabolic Panel 1 NHP Kit C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, PP \| Non-human primate Multiplex
V-PLEX Metabolic Panel 1 Rat Kit GIP (active), GLP-1 (active), Glucagon \| Rat Multiplex
V-PLEX Plus Glucagon Kit Glucagon \| Human, Mouse, Rat, Non-human primate, Canine Singleplex
V-PLEX Plus Human Insulin Kit Insulin \| Human, Non-human primate, Canine Singleplex
V-PLEX Plus Metabolic Panel 1 Canine Kit GIP (active), GLP-1 (active), Glucagon, Insulin \| Canine Multiplex
V-PLEX Plus Metabolic Panel 1 Human Kit C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, Leptin, PP \| Human Multiplex
V-PLEX Plus Metabolic Panel 1 Mouse Kit GLP-1 (active), Glucagon \| Mouse Multiplex
V-PLEX Plus Metabolic Panel 1 NHP Kit C-Peptide, GIP (active), GLP-1 (active), Glucagon, Insulin, PP \| Non-human primate Multiplex
V-PLEX Plus Metabolic Panel 1 Rat Kit GIP (active), GLP-1 (active), Glucagon \| Rat Multiplex
U-PLEX Human GLP-1 (total) Assay GLP-1 (total) \| Human Singleplex
U-PLEX Human Glucagon Assay Glucagon \| Human Singleplex
U-PLEX Human Insulin Assay Insulin \| Human Singleplex
U-PLEX Mouse GLP-1 (total) Assay GLP-1 (total) \| Mouse Singleplex
U-PLEX Mouse Glucagon Assay Glucagon \| Mouse Singleplex
U-PLEX Mouse Insulin Assay Insulin \| Mouse Singleplex
U-PLEX Rat GLP-1 (total) Assay GLP-1 (total) \| Rat Singleplex
U-PLEX Rat Glucagon Assay Glucagon \| Rat Singleplex
U-PLEX Rat Insulin Assay Insulin \| Rat Singleplex
U-PLEX Mouse/Rat Insulin Antibody Set Insulin \| Mouse, Rat
U-PLEX GLP-1 (total) Antibody Set (5 Plate Size) GLP-1 (total) \| Human, Mouse, Rat
U-PLEX Glucagon Antibody Set (5 Plate Size) Glucagon \| Human, Mouse, Rat
U-PLEX Human Insulin Antibody Set Insulin \| Human
V-PLEX GLP-1 (total) Kit GLP-1 (total) \| Human, Mouse, Non-human primate, Rat, Canine Singleplex
V-PLEX Plus GLP-1 (total) Kit GLP-1 (total) \| Human, Mouse, Non-human primate, Rat, Canine Singleplex
GLP-1 (total) Control Pack GLP-1 (total) \| Human, Mouse, Non-human primate, Rat, Canine
Mouse Metabolic Kit Insulin, Leptin \| Mouse Multiplex
Mouse/Rat Insulin Kit Insulin \| Mouse, Rat Singleplex
Human Insulin Kit Insulin \| Human Singleplex
GLP-1 (total) Antibody GLP-1 (total) \| Human
V-PLEX Custom Canine Biomarkers GIP (active), GLP-1 (active), Glucagon, Insulin \| Canine Multiplex

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Safety, pharmacokinetics, and pharmacodynamic effects of a selective TGR5 agonist, SB-756050, in type 2 diabetes.

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