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Table 4 Pharmacokinetic parameters for Posiphen and metabolites in CSF

From: A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer’s Disease

Treatment arm

 

60 mg (n = 4)

60 mg BID (n = 5)

60 mg TID (n = 1)

Posiphen

AUC0 − 24 (hr*ng/mL)

12.29 (31.08)

17.89 (79.06)

24.97

Cmax (ng/mL)

2.85 (26.07)

2.21 (48.09)

2.44

Tmax (hr)

2 (2–2)

2 (2–20)

2

N1 metabolite

AUC0 − 24 (hr*ng/mL)

1.33*

8.75 (83.50)

†

Cmax (ng/mL)

0.66*

0.90 (31.32)

†

Tmax (hr)

4*

12 (4–20)

†

N8 metabolite

AUC0 − 24 (hr*ng/mL)

8.91 (47.91)

17.88 (58.47)

6.26

Cmax (ng/mL)

1.01 (14.14)

1.41 (39.33)

0.62

Tmax (hr)

4 (2–8)

12 (4–20)

12

  1. AUC0 − 24, area under the concentration-time curve from 0 to 24 h; Cmax, maximum observed concentration; Tmax, time of maximum observed concentration. Data presented as geometric mean (% geometric coefficient of variation) except Tmax which is presented as median (min-max). *Only one participant in the 60 mg daily group had measurable concentrations of N1 in CSF.
  2. †The participant in the 60 mg three times daily group did not have measurable concentrations of N1 in CSF.
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Alzheimer's Research & Therapy

ISSN: 1758-9193