The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.
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Mean (Ā± SD) Plasma Pharmacokinetic Concentrations of A4250 Following A Single Oral 10 mg A4250 Dose - Tmax
Timeframe: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Mean (Ā± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - Cmax
Timeframe: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Mean (Ā± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - AUC 0-t
Timeframe: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 4 h Post-Dose
Timeframe: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 24 h Post-Dose
Timeframe: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Mean (SD) Change in C4 from Day 1 Pre-Dose to 4 h Post-Dose
Timeframe: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Mean (SD) Change in C4 from Day 1 Pre-Dose to 24 h Post-Dose
Timeframe: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Mean (SD) Changes in Total Bile Acids for A4250 4 h compared to pre-dose
Timeframe: Samples were taken pre-dose and post-dose at 4 hours and 24 hours.
Mean (SD) Changes in Total Bile Acids for A4250 24 h compared to pre-dose
Timeframe: Samples were taken pre-dose, and post-dose at 4 hours and 24 hours.
Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma FGF19
Timeframe: AUC(0-12) on Day 7 (only for Part II)
Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma C4
Timeframe: AUC(0-12) on Day 7 (only Part II)
Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma Total Bile Acids
Timeframe: AUC(0-12) on Day 7 (only Part II)
Mean (SD) Changes in Faecel Total Bile Acids from Day 1 Pre-Dose on Day 7 at 24 h Post-dose
Timeframe: Change from Day 1 Pre-dose to Day 7 at 24 hours Post-dose
Mean (SD) Change in Faecal Total Bile Acids Excreted (ng) from Day 1 Pre-Dose on Day 7 Post-Dose
Timeframe: Change from Day 1 Pre-dose to Day 7 at 24 hours Post-dose