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. 2019 Dec 10;9(3):395–410. doi: 10.1002/cpdd.762

Table 4.

Summary of PD Parameters of FGF19 Following Single and Multiple Ascending Doses

n AUC0‐24 h (pg • h/mL) Cmax (pg/mL) Maximum Change From Baseline (pg/mL) Difference vs Placebo (pg/mL)
SAD Median (Range) Mean (SD) Median (95%CI)
Dose (µg) 6‐h After Dose
10 5

1250 (1040‐1410)

1230 (138)

438 (337‐773)

489 (168)

265 (156‐665)

313 (205)

196.5 (−0.7 to 384.0)
30 6

980 (733‐2450)

1260 (662)

416 (267‐1520)

609 (479)

312 (168‐1330)

484 (438)

235.4 (60.4‐676.0)
100 6

1450 (1020‐2130)

1540 (498)

673 (325‐991)

704 (252)

607 (291‐795)

578 (213)

534.6 (320.0‐790.0)
300 6

2460 (782‐4900)

2660 (1500)

1440 (447‐1730)

1210 (535)

1250 (353‐1470)

1060 (485)

1120.0 (405.2‐1463.0)
300 (fed) 4

3090 (1720‐5690)

3400 (1910)

1140 (769‐2380)

1350 (726)

976 (567‐2200)

1180 (728)

1000 6

3410 (1730‐4440)

3220 (985)

1820 (1030‐2570)

1820 (630)

1700 (963‐2430)

1680 (597)

1679.0 (1058.0‐2244.0)
3000 6

4240 (2530‐6800)

4470 (1750)

1750 (1400‐3250)

2070 (752)

1570 (1260‐2950)

1860 (682)

1554.0 (1290.3‐2563.0)
MAD Median (Range) Mean (SD) Median (95%CI)
qd Dose (µg) 6‐h After Dose
10 Day 1 9

737 (361‐1470)

806 (352)

360 (215‐605)

380 (126)

270 (7.00‐471)

267 (151)

2.4 (−163.5 to 135.7)
Day 13 9

883 (615‐1030)

860 (151)

405 (177‐613)

375 (126)

245 (−62.0 to 538)

262 (158)

81.35 (−55.6 to 187.3)
30 Day 1 6

1000 (737‐2060)

1210 (529)

626 (469‐1070)

691 (238)

595 (207‐892)

574 (244)

392.8 (113.8‐623.6)
Day 13 6

1330 (602‐2070)

1380 (557)

649 (262‐1040)

607 (290)

538 (248‐737)

490 (197)

357.0 (140.8‐552.7)
30 (obese)a Day 1 7

1040 (435‐1860)

1110 (495)

518 (178‐918)

551 (242)

460 (104‐845)

469 (237)

299.70 (–37.5 to 649.3)
Day 14 7

1050 (648‐1960)

1180 (447)

479 (226‐877)

531 (238)

418 (152‐752)

449 (217)

117.05 (–285.7 to 304.10)
60 Day 1 6

1370 (983‐3140)

1610 (780)

581 (462‐847)

592 (137)

456 (306‐706)

469 (138)

323.2 (131.8‐490.6)
Day 13 6

1140 (640‐2090)

1280 (612)

597 (235‐829)

573 (230)

475 (131‐735)

450 (258)

237.5 (9.2‐529.4)
100 Day 1 6

2320 (1310‐3190)

2240 (725)

936 (428‐1660)

981 (424)

731 (350‐1480)

821 (422)

541.55 (254.80‐1094.0)
Day 13 4

2290 (743‐4000)

2330 (1470)

1150 (309‐1470)

1020 (502)

1050 (231‐1290)

907 (469)

671.65 (144.3‐1179.6)

AUC0‐24h, area under the plasma concentration–time curve from time 0 to 24 h; Cmax, observed maximum plasma concentration following drug administration; CI, confidence interval; FGF19, fibroblast growth factor 19; MAD, multiple ascending dose; PD, pharmacodynamic; qd, once daily; SAD, single ascending dose.

Bolded values indicate P < .05 vs placebo by Wilcoxon rank‐sum test.

a

Day 14 assessment was performed in obese subjects instead of Day 13.

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