Table 3.

Hepatic laboratory parameters.

	Placebo (n = 260)	Ubrogepant 100 mg (n = 256)
ALT, U/L	n = 258	n = 256
Baseline, mean (SD)	20.5 (7.2)	21.1 (9.1)
End of trial, mean (SD)	21.7 (7.7)	21.3 (8.7)
Change from baseline, mean (SD)	1.2 (7.4)	0.1 (8.4)
Post baseline ≥ 3 × ULN, n (%)	3 (1.2)	2 (0.8)
AST, U/L	n = 258	n = 256
Baseline, mean (SD)	21.4 (4.7)	21.5 (5.7)
End of trial, mean (SD)	22.8 (5.2)	22.4 (6.9)
Change from baseline,  mean (SD)	1.4 (5.3)	0.9 (6.8)
Post baseline ≥ 3 × ULN, n (%)	4 (1.6)	0
Total bilirubin, μmol/L	n = 258	n = 256
Baseline, mean (SD)	11.26 (5.20)	10.91 (4.50)
End of trial, mean (SD)	8.76 (4.09)	8.37 (3.33)
Change from baseline,  mean (SD)	−2.50 (4.51)	−2.54 (3.92)
Post baseline ≥ 3 × ULN, n (%)	0	0
ALP, U/L	n = 258	n = 256
Baseline, mean (SD)	67.1 (20.5)	66.6 (18.6)
End of trial, mean (SD)	69.4 (19.6)	68.7 (19.6)
Change from baseline,  mean (SD)	2.3 (9.9)	2.1 (8.3)
Post baseline ≥ 3 × ULN, n (%)	0	0
Post baseline ALT or AST, n (%)	n = 258	n = 256
≥ 1 × ULN	70 (27.1)	68 (26.6)
≥ 1.5 × ULN	16 (6.2)	25 (9.8)
≥ 2 × ULN	11 (4.3)	8 (3.1)
≥ 3 × ULN	5 (1.9)	2 (0.8)
≥ 5 × ULN	3 (1.2)	0
≥ 10 × ULN	1 (0.4)	0
≥ 20 × ULN	0	0
Potential Hy's Law case: ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN and ALP < 2 × ULN	0	0

ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; SD, standard deviation; ULN: upper limit of normal.