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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.