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Table 4 Pharmacokinetic parameters for LY2787106 after single dose and multiple doses

From: A first-in-human phase 1 study of a hepcidin monoclonal antibody, LY2787106, in cancer-associated anemia

  

Single dose

Multiple dose

Study part/dose

N

Cmax (ng/mL)

AUC0-inf (μg·h/mL)

AUCτ,sd (μg·h/mL)

CL (mL/h)

t1/2 (h)

V (L)

AUCτ,ss (μg·h/mL)

Part A

 0.3 mg/kg Q3W

4

5450 (24%)

[4150–7160]

663 (42%)

[414–1063]

597 (38%)

43 (38%)

[28–67]

142 (55%)

[75–260]

8.9 (23%)

[6.8–11.7]

NA

 1 mg/kg Q3W

3

22,300 (27%)

[14,300–35,000]

2146 (64%)

[799–5764]

1799 (50%)

33 (45%)

[16–68]

213 (50%)

[126–241]

10 (7%)

[8.9–11.4]

2337 (41%)

[1206–4530]

 3 mg/kg Q3W

7

79,000 (15%)

[105,000–71,000]

8934 (39%)

[6772–11,788]

7991 (25%)

28 (52%)

[19–40]

172 (54%)

[71–375]

6.9 (21%)

[5.9–8]

9755 (30%)

[7402–12,856]

 10 mg/kg Q3W

5

205,000 (12%)

[183,000–231,000]

24,503 (19%)

[20,485–29,309]

22,457 (16%)

30 (44%)

[20–45]

154 (21%)

[124–197]

6.8 (51%)

[4.3–11]

26,560 (29%)

[20,182–34,952]

 All doses

19

   

32 (46%)

[27–38]

166 (45%)

[72–375]

7.7 (32%)

[6.8–8.7]

 

Part B

 10 mg/kg QW

6

258,000 (15%)

[228,000–292,000]

21,000 (19%)

[17,935–24,590]

16,723 (18%)

35 (29%)

[27–44]

72 (18%)

[57–87]

3.6 (34%)

[2.7–4.7]

24,054 (21%)

[19,754–29,289]

 10 mg/kg QW + iron

5

199,000 (12%)

[178,000–223,000]

16,798 (27%)

[13,031–21,656]

13,261 (24%)

44 (22%)

[36–55]

75 (15%)

[68–96]

4.8 (23%)

[3.9–6]

20,278 (51%)

[11,550–35,600]

Accumulation ratios

  

AUCτ,ss/AUCτ,sd

  

 Part A (Q3W)

13

1.2 (14%) [1.12–1.29]

 Part B (QW)

9

1.55 (21%) [1.36–1.76]

AUCτ,ss/AUC0-inf

13

1.04 (15%) [0.97–1.12]

  1. Values for pharmacokinetic parameters are reported as geometric mean (CV%) [90% CI], except for t1/2 reported as geometric mean (CV%) [range]. Values for accumulation ratios are reported as mean (CV%) [90% CI]
  2. AUC 0-inf area under the plasma concentration versus time curve to infinity after single dose, AUC τ,sd area under the plasma concentration versus time curve over the dosing interval after single dose, AUC τ,ss area under the plasma concentration versus time curve during one dosing interval at steady state, CI confidence interval, CL total body clearance, C max maximum observed concentration, CV% percentage coefficient of variation, Q3W every 3 weeks, QW weekly, t 1/2 mean elimination half-life associated with the terminal rate constant (λz), V volume of distribution
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Journal of Hematology & Oncology

ISSN: 1756-8722

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