Table 1.
Summary of triptorelin and degarelix studies used in the population PK/PD data analysis
| Study | Administration* | Dose† | Subjects | PK samples‡ | LH samples‡ | Te samples‡ |
|---|---|---|---|---|---|---|
| Triptorelin | Single dose | Total | 58 HS | 1152 (35) | 1330 (0) | 1300 (0) |
| s.c. | 3.75 mg | 30 HS | 584 (17) | 672 (0) | 659 (0) | |
| i.m. | 3.75 mg | 28 HS | 508 (18) | 658 (0) | 641 (0) | |
| Degarelix | Repeated dose | Total | 170 PC | 4404 (22) | 4826 (207) | 4827 (233) |
| s.c. (12) | 120@20 | 24 PC | 526 (3) | 592 (13) | 591 (34) | |
| s.c. (10) | 120@40 | 12 PC | 257 (1) | 277 (6) | 277 (14) | |
| s.c. (9) | 160@40 | 12 PC | 233 (0) | 249 (0) | 250 (3) | |
| s.c. (4) | 200@40 | 24 PC | 827 (6) | 900 (36) | 900 (64) | |
| s.c. (4) | 200@60 | 24 PC | 525 (0) | 580 (10) | 579 (8) | |
| s.c. (4) | 240@40 | 23 PC | 777 (4) | 828 (62) | 828 (58) | |
| s.c. (3) | 240@60 | 24 PC | 555 (1) | 607 (37) | 607 (12) | |
| s.c. (3) | 320@60 | 27 PC | 704 (7) | 793 (43) | 795 (30) |
*
Route of administration with average number of degarelix administrations at each dose level.
†
The notation ‘120@20’ represents a dose of 120 mg using a 20 mg ml−1dosing solution.
‡
The numbers in parentheses are the number of samples below LLOQ. PK, Pharmacokinetic; LH, luteinizing hormone; Te, testosterone; HS, healthy subjects; PC, prostate cancer patients; s.c., subcutaneous administration; i.m., intramuscular administration.