よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (34 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_29325.html |
| 出典情報 | 薬事・食品衛生審議会 薬事分科会（令和4年度第5回 11／22）、医薬品第二部会（令和4年度第13回 11／22）（合同開催）《厚生労働省》 |
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S-217622
表 2.5.3.1-10
2.5 臨床に関する概括評価
被験者背景の要約
Study
Background characteristics
Mean (SD)
64.0 (13.0)
Median (range)
63.0 (35.0 - 115.0)
BMI (kg/m2)
22.7 (3.7)
22.0 (14.2 - 37.3)
Age (years)
34.0 (11.9)
32 (12 - 69)
ALT (U/L)
25.2 (25.6)
19 (5 - 287)
AST (U/L)
24.3 (14.2)
21 (12 - 215)
BIL (mg/dL)
0.6 (0.3)
0.5 (0.1 - 1.8)
ALB (g/dL)
4.5 (0.3)
4.5 (3.2 - 5.5)
121.5 (28.5)
118.0 (50.3 - 322.3)
0.75 (0.16)
0.76 (0.37 - 1.26)
92.9 (18.7)
90.9 (49.9 - 156.8)
89.3 (17.9)
87.9 (47.9 - 184.6)
Overall
Body weight (kg)
(N = 443)
CrCL (mL/min)
Scr (mg/dL)
eGFR (mL/min/1.73
m2)
eGFRabs (mL/min)
Formulation (Suspension : Tablet) a
62 (14.0%) : 381 (86.0%)
Sex (Male : Female) a
283 (63.9%) : 160 (36.1%)
Race (Asian : White) a
435 (98.2%) : 8 (1.8%)
Health status (Healthy : Infected by SARS-CoV-2) a
Phase 1 study
(N = 120)
120 (27.1%) : 323 (72.9%)
Body weight (kg)
64.6 (8.4)
64.7 (43.6 - 87.0)
(kg/m2)
22.1 (2.2)
21.8 (18.7 - 27.6)
Age (years)
31.1 (7.5)
30.5 (20 - 52)
ALT (U/L)
18.9 (7.5)
17 (5 - 40)
AST (U/L)
19.3 (3.6)
19 (13 - 28)
BIL (mg/dL)
0.9 (0.3)
0.9 (0.4 - 1.8)
ALB (g/dL)
4.6 (0.3)
4.6 (4.0 - 5.4)
CrCL (mL/min)
122.3 (18.3)
119.3 (89.0 - 197.3)
Scr (mg/dL)
0.79 (0.14)
0.79 (0.47 - 1.22)
94.1 (14.9)
92.2 (60.6 - 133.2)
92.6 (13.8)
89.8 (64.2 - 130.4)
BMI
eGFR (mL/min/1.73
m2)
eGFRabs (mL/min)
b
Food condition
(Other : Administration within 2 hours after meal) a
119 (89.5%) : 14 (10.5%)
Formulation (Suspension : Tablet) a
62 (51.7%) : 58 (48.3%)
Sex (Male : Female) a
104 (86.7%) : 16 (13.3%)
Race (Asian : White) a
112 (93.3%) : 8 (6.7%)
Health status (Healthy : Infected by SARS-CoV-2)
Phase 2a Part
and Phase 2b
Part
(N = 323)
a
120 (100.0%) : 0 (0.0%)
Body weight (kg)
63.7 (14.4)
62.0 (35.0 - 115.0)
(kg/m2)
22.9 (4.1)
22.0 (14.2 - 37.3)
Age (years)
35.1 (13.0)
33 (12 - 69)
ALT (U/L)
27.6 (29.3)
19 (8 - 287)
AST (U/L)
26.2 (16.1)
23 (12 - 215)
BIL (mg/dL)
0.5 (0.2)
0.4 (0.1 - 1.6)
ALB (g/dL)
4.5 (0.3)
4.5 (3.2 - 5.5)
CrCL (mL/min)
121.1 (31.5)
117.4 (50.3 - 322.3)
Scr (mg/dL)
0.73 (0.17)
0.73 (0.37 - 1.26)
92.4 (20.0)
90.5 (49.9 - 156.8)
BMI
eGFR (mL/min/1.73
m2)
- 34 -
表 2.5.3.1-10
2.5 臨床に関する概括評価
被験者背景の要約
Study
Background characteristics
Mean (SD)
64.0 (13.0)
Median (range)
63.0 (35.0 - 115.0)
BMI (kg/m2)
22.7 (3.7)
22.0 (14.2 - 37.3)
Age (years)
34.0 (11.9)
32 (12 - 69)
ALT (U/L)
25.2 (25.6)
19 (5 - 287)
AST (U/L)
24.3 (14.2)
21 (12 - 215)
BIL (mg/dL)
0.6 (0.3)
0.5 (0.1 - 1.8)
ALB (g/dL)
4.5 (0.3)
4.5 (3.2 - 5.5)
121.5 (28.5)
118.0 (50.3 - 322.3)
0.75 (0.16)
0.76 (0.37 - 1.26)
92.9 (18.7)
90.9 (49.9 - 156.8)
89.3 (17.9)
87.9 (47.9 - 184.6)
Overall
Body weight (kg)
(N = 443)
CrCL (mL/min)
Scr (mg/dL)
eGFR (mL/min/1.73
m2)
eGFRabs (mL/min)
Formulation (Suspension : Tablet) a
62 (14.0%) : 381 (86.0%)
Sex (Male : Female) a
283 (63.9%) : 160 (36.1%)
Race (Asian : White) a
435 (98.2%) : 8 (1.8%)
Health status (Healthy : Infected by SARS-CoV-2) a
Phase 1 study
(N = 120)
120 (27.1%) : 323 (72.9%)
Body weight (kg)
64.6 (8.4)
64.7 (43.6 - 87.0)
(kg/m2)
22.1 (2.2)
21.8 (18.7 - 27.6)
Age (years)
31.1 (7.5)
30.5 (20 - 52)
ALT (U/L)
18.9 (7.5)
17 (5 - 40)
AST (U/L)
19.3 (3.6)
19 (13 - 28)
BIL (mg/dL)
0.9 (0.3)
0.9 (0.4 - 1.8)
ALB (g/dL)
4.6 (0.3)
4.6 (4.0 - 5.4)
CrCL (mL/min)
122.3 (18.3)
119.3 (89.0 - 197.3)
Scr (mg/dL)
0.79 (0.14)
0.79 (0.47 - 1.22)
94.1 (14.9)
92.2 (60.6 - 133.2)
92.6 (13.8)
89.8 (64.2 - 130.4)
BMI
eGFR (mL/min/1.73
m2)
eGFRabs (mL/min)
b
Food condition
(Other : Administration within 2 hours after meal) a
119 (89.5%) : 14 (10.5%)
Formulation (Suspension : Tablet) a
62 (51.7%) : 58 (48.3%)
Sex (Male : Female) a
104 (86.7%) : 16 (13.3%)
Race (Asian : White) a
112 (93.3%) : 8 (6.7%)
Health status (Healthy : Infected by SARS-CoV-2)
Phase 2a Part
and Phase 2b
Part
(N = 323)
a
120 (100.0%) : 0 (0.0%)
Body weight (kg)
63.7 (14.4)
62.0 (35.0 - 115.0)
(kg/m2)
22.9 (4.1)
22.0 (14.2 - 37.3)
Age (years)
35.1 (13.0)
33 (12 - 69)
ALT (U/L)
27.6 (29.3)
19 (8 - 287)
AST (U/L)
26.2 (16.1)
23 (12 - 215)
BIL (mg/dL)
0.5 (0.2)
0.4 (0.1 - 1.6)
ALB (g/dL)
4.5 (0.3)
4.5 (3.2 - 5.5)
CrCL (mL/min)
121.1 (31.5)
117.4 (50.3 - 322.3)
Scr (mg/dL)
0.73 (0.17)
0.73 (0.37 - 1.26)
92.4 (20.0)
90.5 (49.9 - 156.8)
BMI
eGFR (mL/min/1.73
m2)
- 34 -