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)
|
- †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.
- ‡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.
- *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.
- **Two subjects were not evaluable for PK on Day 19 due to AE-related dose reduction.