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Table 2 Pharmacokinetic parameters for ridaforolimus following a single oral dose or multiple once daily oral dosages of 40 mg of ridaforolimus in Chinese patients with advanced or metastatic solid tumors

From: A phase I study of ridaforolimus in adult Chinese patients with advanced solid tumors

Pharmacokinetic parameter

Ridaforolimus

N

Mean

95% CI

Day 1*

Tlag (hr)

15

2.00

(0.97, 8.07)

AUC0-24 (ng.hr/ml)

13

1846

(1361, 2503)

AUC0-∞ (ng.hr/ml)

13

3648

(3044, 4372)

Cmax (ng/ml)

13

210

(150, 295)

C24hr (ng/ml)

15

34.8

(26.0, 46.8)

Tmax (hr)

13

4.03

(2.00, 7.97)

Apparent t1/2 (hr)

15

52.9

(40.2, 65.6)

Day 19**

AUC0-24 (ng.hr/ml)

13

2014

(1485, 2731)

Cmax (ng/ml)

13

167

(119, 234)

C24hr (ng/ml)

13

49.7

(36.4, 67.7)

Tmax (hr)

13

4.00

(0.00, 6.00)

  1. Back-transformed least-squares mean and confidence interval from a linear mixed-effect model, containing a fixed effect for day and a random effect for subject, performed on natural log-transformed values.
  2. Geometric Mean and back-transformed 95% CI for AUC0-24hr, AUC0-∞, Cmax, and C24hr. Harmonic Mean and jackknife SD for T1/2. Median and Range (Min, Max) for Tlag and Tmax.
  3. *Both for Day 1 and Day 19 no samples were taken between 8 hr and 24 hr post dose. However, for some patients no concentration levels above the lower limit of quantification could be obtained until 8 hr post dose on Day 1. Consequently some PK parameters could not be calculated for these patients. In addition, Tlag was presented for all patients on Day 1.
  4. **Two subjects were not evaluable for PK on Day 19 due to AE-related dose reduction.